Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: h&h medical emergency cricothyrotomy kit
the united states food and drug administration (fda) has issued a medical device safety alert concerning emergency cricothyrotomy kit, manufactured by h&h medical corporation. the affected products are identified as follows:-
lot number: ckbd033, ckbe033, ckbd034, ckbf034, ckbg034, ckbp045, ckbp047, ckbq047, ckbr060, ckbt065, ckbv070, ckbw070, ckbx070, ckbx071, ckbx076, ckbx078, ckbx079, ckby079, ckby080, ckbz080, ckca080
the products were manufactured from 16 august 2012 and 29 july 2013
the manufacturer initiated a nationwide recall of 6,619 units of the h&h emergency cricothyrotomy kit on 27 august 2013. the product has been found to show the potential for a defective cuff balloon on the provided endotracheal airway.
the cuff balloon may be defective due to a very particular set of circumstances (a reduction in package density, a higher than average dose of gamma sterilization, and the occasional slippage of a protective silicon sleeve during shipping used to shield the cuff balloon at the end of the endotracheal airway). to date, the fda and the manufacturer have not received any injuries or deaths.
the manufacturer is notifying its distributors and customers by telephone and/or email and is arranging for correction of all affected products.
for details, please visit the following fda websites:
http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm370781.Htm
http://www.Fda.Gov/safety/recalls/ucm370775.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 7 october 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hitachi high technologies corporation sample probe connectors
roche diagnostics has issued a medical device safety alert concerning probe sample (gmmi 04547241001), probe sample s (gmmi 05899427001) and sample probe (gmmi 04945794001), manufactured by hitachi high technologies corporation.
the following roche analysers have been delivered with potentially affected sample probes:
cobas c 501 module (cat. no. 04745914001); cobas c 502 module (cat. no. 05964067001); cobas c 702 module (cat. no. 06473245001); cobas 8000 ise module 900 (cat. no. 05641497001); cobas 8000 ise module 1800 (cat. no. 05964075001).
in very rare cases, a disturbance of the sample liquid level detection (lld) may occur due to a fretting corrosion on the sample probe connector due to a production change for the connector. in those very rare cases where the disturbance of the sample liquid level detection (lld) occurs, the affected sample probe may dip into the sample material deeper than intended, accordingly the affected sample probe may be not washed adequately (this may lead to carryover, medical risk cannot be excluded).
the manufacturer, hitachi high technologies corporation, has clearly identified the root cause and since the beginning of 2017, the affected sample probe connector type has been changed in production to a new connector type. with that new connector type the sample lld is ensured to fully function as specified.
affected users are instructed to take the following actions:-
enable the “clot detection” and “clot detection for calib./control” settings in “utility-system-alarm settings” “how to proceed whenever the system alarm “sample short” or “abnormal aspiration” is issued” relevant to the analyzer/module type used in their laboratory).
until the sample probe exchange takes place, whenever the analyzer issues the system alarm “sample short” or “abnormal aspiration” for a sample with sufficient sample volume, affected users follow the instructions in the attachment(s) “how to proceed whenever the system alarm “sample short” or “abnormal aspiration” is issued” relevant to the analyzer/module type used in their laboratory.
if carryover cannot be excluded, affected samples should be handled according to the local regulations including the decision whether previously generated results should be reviewed.
according to the local supplier (roche diagnostics), the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 10 march 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: halyard health (kimberly-clark) kimvent* subglottic suctioning endotracheal tubes
medical device manufacturer, halyard health, inc. (formerly known as kimberly-clark health care) has issued a field safety notice concerning its kimvent* microcuff* subglottic suctioning endotracheal tube, 8.0mm. the affected product code is 13222. the affected lot numbers, shipped from 20 december 2013 to 30 october 2014, are aa3213, aa3213v03, aa3227, aa3227v01, aa3239, aa3239v01, aa3245, aa3245v02, aa3249, aa3249v01, aa3249v03, aa3253v02, aa3269v01, aa3274, aa3274v01, aa3274v04, aa4038, aa4038v03, aa4038v04, aa4038v06, aa4062, aa4062v01, aa4062v03, aa4062v04, aa4083, aa4083v02, aa4097, aa4097v02, aa4097v04, aa4104v01, aa4104v02, aa4111, aa4111v01, aa4111v02, aa4113v01, aa4125v03, aa4134v01, aa4146v01, aa4146v04, aa4155v03, aa4167v01, aa4170v01, aa4174v01, aa4217v01 and aa4226v01. according to the manufacturer, the standard kimvent* microcuff* endotracheal tubes are not impacted.
the manufacturer has identified that the inflation line of certain kimvent* microcuff* subglottic suctioning endotracheal tubes may detach from the endotracheal tube during use. in most reported cases, detachment of the inflation line was identified immediately, while in other cases, eventual decrease in ventilator circuit pressure triggered ventilator alarms. in the majority of occurrences, re-intubation of the patient was required to re-establish the desired pressure in the ventilator circuit. one suspected case of ventilator associated pneumonia was reported after inflation line detachment, which resolved with standard antibiotic treatment.
the manufacturer has initiated a voluntary product recall on the affected lots of devices.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 24 november 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hamilton medical ag hamilton-t1 ventilator
it has come to our attention that medical device manufacturer, hamilton medical ag, has initiated a field safety corrective action concerning hamilton-t1 ventilator with software version <= 1.1.2.
according to the manufacturer, there is unexpected high internal oxygen consumption of hamil ton-t1 ventilators during ventilation of small pediatric patients. the current labeling does not include sufficient information about the internal oxygen consumption of the ventilators. depending on the ventilator setting and the patient's lung impedance, the internal gas consumption of the hamilton-t1 may be higher than expected. the internal oxygen consumption has to be taken into account in addition to the oxygen requirements for the patient's ventilation, especially when oxygen is limited. if the available oxygen supply during transport is depleted, the life of the patient may be endangered.
furthermore, the manufacturer will rework and provide updated hamilton-t1 labeling (e.G., operator's manual), and develop and provide updated software with optimized internal oxygen consumption and overall oxygen consumption monitoring. it also advises users to calculate the required oxygen capacity prior to transports.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 04 january 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hamilton medical ag intellicuff standalone
medical device manufacturer, hamilton medical ag, has issued a medical device safety alert concerning its intellicuff standalone. the model number involved is pn 951001 and the affected serial numbers are from 1000 to 2090.
the manufacturer’s analysis of a customer complaint has identified an issue relating to the performance of the motor in the intellicuff standalone device. during use, the motor may cease to function. the alarm sounds and the red leds blink in all segments. the intellicuff standalone must be switched off to silence the alarm. the number of failures is unacceptably high causing nuisance alarms and customer complaints.
according to the manufacturer’s assessment, there is no risk for the patient or user related to this failure.
product recall and replacement is on-going.
the manufacturer will provide the necessary hardware improvements for intellicuff standalone devices.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 12 june 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hamilton medical ag hamilton-c2 (pn 160001) and hamilton-c3 (pn 160005) ventilator unit
the medicines and healthcare products regulatory agency (mhra) of the united kingdom (uk) has issued a medical device safety alert concerning hamilton-c2 (pn 160001) and hamilton-c3 (pn 160005) ventilator unit, manufactured by hamilton medical ag.
the analysis of a customer complaint has identified an issue relating to the battery charge of the hamilton-c2/c3 batteries after a usage of two and a half years. the battery fuel gauge may indicate a higher battery charge as to what is available. the technical failure 444001"low battery" high priority alarms are triggered, alerting the operator both acoustically and visually before entering ambient mode.
according to the manufacturer, when batteries are depleted, the operator is alerted by high priority alarms and if the ventilator is not immediately connected to an ac power outlet, the ventilator will switch into ambient mode. the alarm is triggered in every case to alert medical staff.
the affected users are instructed to take the following actions:-
the operator should make themselves familiar with the batteries' manufacturing date and react in time if battery is more than two years old. any battery with a manufacturing date to two years prior to the current date should be replaced.
if the battery is less than two years old, return battery to slot, pushing until clip clicks into place, locking in the battery. use a screwdriver to lock metal clip back into place over battery. close battery door.
for details, please refer to the mhra website:
https://www.Gov.Uk/drug-device-alerts/field-safety-notice-29-august-to-1-september-2017
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 5 september 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hangzhou clongene biotech clungene hcg pregnancy test
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning clungene hcg pregnancy test, manufactured by hangzhou clongene biotech co., ltd. with the following details:
lot no.: 13122001 and 14060301
types: strip, cassette and midstream
the clungene hcg pregnancy test midstream (lot 13122001 and 14060301) gave 17 false positive results at 5 ireland healthcare facilities from 12th june 2014 to 7th august 2014. the manufacturer tested the reserved samples of lot13122001, lot14060301 in the factory and returned 20pcs sticks from distributor, and all test results are passed.
the manufacturer revised the package insert as the old version didn’t state it unequivocal. sometimes, certain medications and endogenous substances in urine can lead to false positive results. the potentially interfering substances which will not interfere the assay when below a certain concentration were added in the new package insert as well.
the manufacturer revised the package insert as the old version didn’t state it unequivocal. sometimes, certain medications and endogenous substances in urine can lead to false positive results. the potentially interfering substances which will not interfere the assay when below a certain concentration were added in the new package insert as well.
for details, please refer to the following link:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con457620
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 30 sep 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: health & life ez breathe atomizer
the united states food and drug administration (fda) has issued a medical device safety alert concerning ez breathe atomizer, manufactured by health & life co. ltd. and distributed by nephron pharmaceuticals corporation. the ez breathe atomizer can be found in these three presentations:
1. packaged in the asthmanefrin starter kit, ndc 0487-2784-10
2. ez breathe atomizers model # 100+
3. replacement medication cup
the affected serial/lot numbers are as follows:
1. r2029a, r2029b, r2039a, r2042a, r2045a, and r2047a
2. 1206034476 – 1206069065, 1209069180 – 1209069202, 1207003710 – 1207038299, 1209069203 – 1209069460, 1207046505 – 1207081124, 1210000001 – 1210103680, 1208027421 – 1208062155, 1210104001 – 1210104044, 1209000001 – 1209069179
3. 120902, 120903 and 120904
according to the fda, a medical device recall was issued after health & life co., ltd. became aware of a manufacturing defect which could result in the washer ("plate a") becoming dislodged from the ez breathe atomizer. if this occurs, users may accidentally swallow the washer or choke on it, which can lead to serious adverse health consequences or death.
the manufacturer has notified customers of the problem and products affected. customers should stop using any ez breathe atomizer units contained in the asthmanefrin starter kits with the affected lot numbers and also those that were sold individually.
for details, please visit the following fda websites:
http://www.Fda.Gov/safety/medwatch/safetyinformation/safety
alertsforhumanmedicalproducts/ucm355037.Htm
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm355016.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 04 june 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: heart sync inc. multi-function defibrillation electrodes
the united states food and drug administration (fda) posted a medical device safety alert concerning multi-function defibrillation electrodes manufactured by heart sync inc. all lots of the following catalogue numbers are affected:
c100-philips - adult radiotransparent electrode
c100ac-philips - adult radiotransparent electrode
t100lo-philips - adult radiotransparent electrode
t100-philips radiotranslucent electrode
t100ac-philips radiotranslucent electrode
the manufacturer notified customers of a voluntary urgent device correction for certain multi-function defibrillation electrodes due to a connector compatibility issue with philips automated external defibrillators (aed) models fr3 and frx defibrillator units. these electrodes will not connect with philips fr3 or frx aed units. the frx aed unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. the fr3, however, does not require pre-connection and the user will not discover the incompatibility issue until the aed must be used. this may result in a delay in electrical therapy, which can lead to death or serious adverse consequences. the manufacturer is modifying the labeling to clarify that use of the affected electrodes are incompatible with certain aed units.
philips fr3 and frx aed units should only be used with the electrodes specified in the equipment manuals.
for details, please refer to the following link:
http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm425605.Htm
http://www.Fda.Gov/safety/recalls/ucm425536.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 4 december 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Press release
Causa
Recall of silicone-filled breast implants the department of health (dh), through its routine surveillance today (march 31), found that a french regulatory authority has announced a recall of the silicone-filled breast implants manufactured by poly implant prothese (pip).
the affected models include imghc-tx, imghc-mx and imghc-ls.
there is an increase of reported adverse events concerning the problematic products in the past three years. they are mainly breakings and local complications.
despite the fact that the products are not listed with dh, the department considered that there may be quality defects and safety concerns of the products after risk assessment.
dh decided to inform stakeholders including hospital authority, hospitals and medical professional association about the recall.
information on the recall has been posted on the dh's website.
members of the public who have implanted with the affected products, or in case of doubt, should consult their doctors.
the dh has not received any report of adverse events arising from the affected products.
the department will closely monitor the developments of the recall.
ends/wednesday, march 31, 2010.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Sweden suggests prophylactic pip breast implant removal
the medical products agency and the national board of health and welfare in sweden published updated recommendations regarding silicone breast implants manufactured by poly implant prothèse (pip).
these changes to the recommendations are based on an analysis of the new studies of pip implants which have been conducted in sweden and abroad.
pip implants have been shown to have a coating which has poor durability. this increases the risk of rupture when compared with other brands of silicone breast implant.
the medical product agency's investigation has shown that there are two types of pip implant, manufactured from different types of silicone. one type of silicone contains a substance octamethylcyclotetrasiloxane (d4) which is irritant to tissues. this is present in such quantity that it may constitute a risk of serious inflammation in surrounding tissues.
a leak of d4 from the pip implant into the surrounding tissues cannot be excluded as the cause of local inflammation.
the possible long-term effects of chronic inflammation caused by silicone containing d4 cannot be determined.
the groups of women who have pip implants are relatively young and may be expected to carry their breast implants for a very long time.
it is also not possible, with any certainty, to identify which type of silicone is in any woman's pip implants.
based on these findings, the medical products agency and the national board of health and welfare will recommend the followings based on the precautionary principle:
clinics that have implanted pip implants should contact the women concerned to inform them about the state of knowledge and about the risks of keeping the pip implants in relation to the risks of undergoing an operation to remove the pip implants.
clinics that have implanted pip implants should remove them. this should be done as a preventative measure even in cases where there are no indications of problems. in individual cases, there may, with reference to the patient's current health situation, be medical reasons to refrain from removing the pip implants.
clinics that have implanted pip implants should make any women who choose not to have their pip implants removed aware of the signs of rupture or of the symptoms of inflammation in the breast area, and, if these occur, it is recommended that they consult a doctor and also that they have the pip implants removed. the signs of rupture or inflammation could be changes in the shape of the breast, lumps, pain, swelling, swollen lymph nodes etc. in or around the breast and armpit.
for more information, please refer to the website of the medical products agency, sweden:
http://www.Lakemedelsverket.Se/english/all-news/nyheter-2013/
pip-implants-should-be-removed-for-preventative-reasons/
posted on 05 jun 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Press release
Causa
Adverse events related to poly implant prothese breast implants a spokesman for the department of health (dh) said today (december 22) the department is aware that the french medical device regulatory authority, afssaps, is continuing to monitor adverse events reported in patients with silicone gel breast implants manufactured by a french company named poly implant prothese (pip).
on december 21, dh was informed by the afssaps of their updated figures on serious adverse events related to pip breast implants. this included a fatal case of anaplastic large cell lymphoma (alcl), a rare form of cancer of the immune system, which was earlier reported in november.
however, it was not possible for them to conclude whether pip implant was an additional risk.
dh noted that to date, the french authority has not made any decision on the need to remove the pip implants, and that an expert meeting is expected to provide further recommendations on the management and follow-up of patients with such implants.
“dh has contacted afssaps to obtain further information and sought their assistance to obtain information about distribution of the affected products in hong kong.” he said.
in march 2010, the afssaps has made a decision to recall and suspend the marketing, distribution, export and the use of the silicone gel breast implants manufactured by pip, as there were increased reports of ruptures of the implants due to quality defects. a press release was also made by dh on march 31, 2010 in response to afssaps’ announcement.
in hong kong, dh has so far not received any report of adverse events associated with pip breast implants. meanwhile, the department will closely follow up with the recommendations issued by afssaps and other medical device regulatory authorities.
members of the public who have received breast implants, particularly those implanted with the affected products, should continue to routinely monitor their breast implants and consult their implanting surgeons if they have any concerns or doubt.
“the department will closely monitor the situation,” the spokesman added.
ends.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Press release
Causa
Recommendation by the french authority on removal of pip breast implants a spokesman for the department of health (dh) said today (december 23) the department noted the recommendation by the french ministry of health regarding the management of patients implanted with silicone gel breast implants manufactured by the french company, poly implant prothese (pip).
the french ministry of health announced today its recommendation for patients to remove their pip silicone gel breast implants as a preventive measure.
the decision was made after an expert meeting, which found that women with pip implants did not have a higher risk of cancer than women with implants made by other companies, but that there were well-established risks of ruptures.
“since the issue came to our attention, dh has been contacting the french medical device regulatory authority, agence francaise de securite sanitaire des produits de sante (afssaps) to obtain information, and sought their assistance to ascertain the distribution of the affected products in hong kong.”the spokesman said.
“according to afssaps, the french manufacturer of the products has closed down in 2010. official data on the distribution and usage of the products in hong kong are not available,” he explained.
“however, based on the information at hand, the product is not popular in hong kong,” he said.
dh noted that while individual health authorities may recommend the removal of pip implants as a precautionary measure, other health authorities have not recommended their removal.
the spokesman reiterated that members of the public who have received breast implants, particularly those implanted with the affected products, should consult their implanting surgeons or surgeons experienced in this field if they have any concerns or doubt.
so far, the department has not received any adverse events in relation to the pip breast implants.
"the department will continue to closely monitor the situation," the spokesman added.
end.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hill-rom affinity® four birthing bed
medical device manufacturer, hill-rom, has issued a field safety notice concerning affinity® four birthing bed.
hill-rom found that some of the affinity® four birthing beds, with serial number h331aa4785 through n081aa7966 produced prior to march 21, 2012, may experience problems with the brakes. the problem may result in unwanted bed movement.
the manufacturer has developed an enhanced braking system for these beds and will modify the affected beds. the manufacturer also advised users to test the brake of the beds to make sure that it operates as normal until installation of the new braking system.
according to the local supplier, solar-med limited, the affected devices were distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 07 may 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hill-rom versacare bed
medical device manufacturer, hill-rom, has issued a medical device safety alert concerning versacare bed (revision e through j, serial number h345ad5880 through n138al9061).
according to the manufacturer, hill-rom versacare bed has a built-in safety feature intended to protect the patient under certain conditions where bed movement could cause harm. this functional lockout feature is designed to disable the bed. however, the manufacturer has received complaints that the lockout is occurring on the bed of the captioned model when it should not.
after an extensive review of this issue, the manufacturer has determined that the majority of these lockouts are related to technical problem on the printed circuit (pc) board within each versacare bed siderail. the manufacturer has identified the root cause to an intermittent connection between a chip and socket on the pc board. the manufacturer will provide a correction for the chip/socket problem which involves replacement of the pc boards in both head-end siderails.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 29 august 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hill-rom dynamis and gerialit beds with dewert electrical system
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning dynamis and gerialit beds manufactured between october 1995 and june 2001 with dewert electrical system, manufactured by hill-rom. the affected model numbers are li146b1—li146bi, li146d1—li146di, li147b1—li147d1, li150a0—li150b0, li163b1—li163c1, prs0128, prs0199, prs0201, prs2001.
the manufacturer wants to make aware of a potential safety issue regarding dynamis and gerialit beds manufactured and shipped from october 1995 to june 2001 that have dewert control boxes. it is possible for there to be unintentional movement of the bed when it is plugged in, including sudden collapse to the lowest position.
in an effort to mitigate the potential for injury, the manufacturer requested customers that the labels should be applied to both sides of the bed as a reminder where a hand should not be placed, and to not climb under the bed.
the manufacturer also advised customers to make sure that staff, patients, caregivers, and visitors do not work or crawl under any bed or other areas where unintended quick return to lowest position or collapse of the bed could cause entrapment that serious injury of death could occur.
for details, please refer to mhra website
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/
fieldsafetynotices/con226926
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 29 january 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hill-rom centuris p750 beds
medical device manufacturer, hill-rom, has issued a medical device safety alert concerning its centuris p750 beds [model number: p75051x, p75052x, p75061x, p75062x, p75071x, p75072x, p75081x, p75082x, p750askd and p750a000001; serial number: from o348cc0046 to r365cc6446].
the manufacturer has received reports of the centuris p750 bed side rail lockout indicators flashing/ blinking and the bed controls getting locked. the bed reset controls may help to resolve the issue in certain circumstances but not always. after an extensive review of this issue, the manufacturer has determined that the majority of these lockouts are related to a technical problem on multiple printed circuit boards (pcbs) within each centuris bed.
based on a thorough health hazard evaluation and availability of a manual release for cpr, the manufacturer has determined that the centuris beds are safe. while awaiting correction, affected users may continue to use the device and maintain awareness of the bed reset controls.
according to the local supplier, the affected products are distributed in hong kong
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 23 march 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: liko standard slingbar 450
it has come to our attention that medical device manufacturer, liko, has initiated a field safety corrective action concerning standard slingbar 450. the affected product numbers are 20090029, 20190024, 20190041, 31190015, 31290017, 31290043, 3156001, 3156003, 3156007, 3156014, 3156016, 31590043 or 5019013 (distributed between jan 1980 and nov 2012). the affected product numbers may be bundled with the golvo 1000, 3000, and 7000 series lifts, viking m, viking l, likolight 100 & 125, caroli 101, and uno 100, 101 & 102.
the manufacturer has become aware of a safety issue related to the standard slingbar 450, which could be attached to various liko overhead and mobile lifts. a serious injury to a patient, caregiver or bystander could result from tripping or otherwise falling into the sling bar, typically when the lift is parked or stored when not in use. the sling hook on the end of the sling bar could pierce a body structure such as the head, shoulder or groin.
the manufacturer advises users to continue to follow safe lifting practices, and not to allow unauthorized persons, especially children, to play around or operate the lift. the current standard slingbar 450 model is designed in such a way that impalement may occur. liko has designed a safety cover to put on the top of the sling bar in order to reduce the risk of impalement. the manufacturer will provide affected customers modification kits. the customers will implement the correction themselves. where needed, a hill-rom technician or third party will complete the correction.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 20 may 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: liko bathing chair
it has come to our attention that medical device manufacturer, liko ab (a hill-rom company) has issued a field safety notice regarding all serial numbers of bathing chair with the following model numbers: 3156025 and p3156025.
the liko bathing chair is an accessory to overhead lift devices. an event occurred in a public pool area in sweden where it was alleged that a patient fell out of the chair during a lift. the patient allegedly suffered serious injuries.
the complaint investigation revealed the device was used without securing the safety belt, which is designed to keep the patient stabilized in the chair during the lift. the safety belt is secured to the chair and cannot be moved. it cannot be unnoticed to be used as part of the safe use of the device. the manufacturer has assessed the risk not likely to occur again in the lifetime of the device.
the manufacturer has created a label reminding users to secure the patient with the safety belt and a new user instruction guide on how to safely use the chair. a modification kit including the label and an updated user guide will be sent to affected users.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 10 october 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Field safety notice: impulse dynamics optimizer® iii implantable pulse generator
medical device manufacturer, impulse dynamics, has issued a field safety notice concerning optimizer® iii implantable pulse generator (ipg).
impulse dynamics recently received four reports from germany concerning the optimizer iii ipg. one of the device components, the reed switch, became stuck during ipg recharge. when it became stuck the devices went into "magnet mode" which is a setting which automatically turns off cardiac contractility modulation therapy. this state can typically be changed to reinitiate therapy by reprogramming the optimizer® iii device with the omni programmer. however, a stuck reed switch affects the telemetry reception by the ipg, preventing reprogramming until the reed switch is released. the event does not present a significant risk to continued use of the device.
according to innotronik hong kong limited, the affected device has been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: horiba abx sas yumizen h500 ct (closed tube) (version 2.1.0 or lower)
the medicines and healthcare products regulatory agency (mhra) of the united kingdom has posted a medical device safety alert concerning yumizen h500 ct (closed tube) (version 2.1.0 or lower), manufactured by horiba abx sas.
product development activities by the manufacturer have shown that a defective positioning of the sampling needle could, in some instances, lead to a wear of the rinsing header ring of the needle.
this technical issue could generate an over estimation of platelet counting. this background is usually detected when a blank cycle is performed at instrument start up (failed start up alarm).
however, in other cases, the blank cycle does not detect the potential abnormal platelet background and could generate erroneous value of platelet counting. the potential overestimation of the platelet counting value could be critical for patients with thrombocytopenia and notably with severe thrombocytopenia which could then not be detected as severe.
a corrective action has been identified by the manufacturer which consists of:
new sampling needle adjustment
needle ring replacement
the manufacturer’s technician will implement the corrective action on affected yumizen h500 ct analyzer. while waiting for the corrective action, the manufacturer recommends the following solution for the patient samples with low platelet value suspicion:
perform a blank cycle
if blank cycle failed, re-run blank cycle
if blank cycle passed, re-run their patient sample
compare the 2 sample run values and repeat the procedure in case of significant discrepancy.
for details, please refer to the mhra’s website:
https://www.Gov.Uk/drug-device-alerts/field-safety-notice-3-to-7-july-2017
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 11 july 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hoya one-piece intraocular lenses
medical device manufacturer, hoya corporation issued a medical device safety alert concerning hoya one-piece intraocular lenses (iol). the affected models are:
ny-60 (hoya af-1 imics1)
311 (hoya af-1 toric)
250 and 251 (hoya isert)
351 (hoya isert toric)
last month, hoya surgical optics announced a voluntary suspension of shipment of five of their products while they investigated reports of higher than expected rates of inflammation and/or endophthalmitis from doctors using ny-60, isert 250, and isert 251 iols in a few countries. an extensive review of manufacturing process revealed that some products had trace residual foreign particulates on them. the manufacturer has been unable to definitively determine if they were linked to the adverse events but the potential may exist. although no adverse events have been reported with the toric lenses, they were included in the recall because they follow a similar manufacturing process.
the manufacturer clarified that no other hoya iols, in particular no three-piece iols, are affected by this recall.
according to the manufacturer, this issue may lead to post-operative inflammation and/or endophthalmitis. however, there is no evidence, and no reports of any new cases of inflammation and or endophthalmitis associated with the iols that have been implanted for six months or longer.
product recall is ongoing. furthermore, for any patient already implanted with one of the lenses included in this recall, hoya recommends following the patient for three to six months post-operatively to monitor for the possible onset of ocular inflammation.
according to the local supplier, hong kong medical supplies ltd., the affected products have been distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 22 february 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hpc healthline gn85 violet accelerator free nitrile examination gloves
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning gn85 violet accelerator free nitrile examination gloves, manufactured by hpc healthline. the affected products are manufactured during april 2013. the affected lot numbers are pp003734-326010413 (sizes small, medium, large, extra-large); and pp003781-126010413 (sizes small, medium and large).
a primary manufacturing stage fault was detected in the raw material preparation, whereby the anti-ageing chemical addition was insufficient during the production of the two batches above. this has resulted in a thermal reaction initially causing a yellowing cuffs and premature ageing of the cuff area with time. the gloves will continue to radiate heat which is detectable through the packaging. when packed on a pallet the internal cases on the stack hold the heat causing the temperature to rise and ultimately the gloves will start to smoulder and could ignite when exposed to air.
the manufacturer has the following recommendations for the affected users:
should the cases feel warm to the touch then douse with water and move the cases to an external location away from the building.
should the cases show signs of smouldering then again douse with water and contact your local fire service who will help to make the product safe for removal to an external location.
if the cases are cool to the touch, quarantine in an external safe location. hpc will conduct a risk assessment and remove the product. if the cases are deemed unsafe to move then disposal shall be arrange at location with a hazardous waste collector.
for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con297539
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 7 august 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hsin ten electro reflex energizer
health canada has issued a type iii recall concerning electro reflex energizer, (model no. sr001a2, serial no. 828015484 to 828015813) manufactured by hsin ten enterprise canada, inc.
the manufacturer found a defective part caused some devices to malfunction where there was no indicator light, no beeping sound and weak or no pulse when the device was on.
according to the local supplier, the affected model is not distributed in hong kong.
for details, please refer to health canada website
http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait
/_list/rec-ret_md-im_date_apr-june_2012-eng.Php
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 03 may 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Press release
Causa
Recall of blood glucose meters with incorrect readings (i-sens model caresens ii) the department of health today (april 23) alerted the public and the medical sector, of a voluntary recall of a type of blood glucose meter (bgm)which displayed falsely low readings.
dh immediately looked into the case upon receiving notification from an informant that two bgm manufactured by i-sens inc, were found to display falsely low readings.
it was revealed that only one specific lot (lot no. isp11e02101 – isp11e02600) of the bgm was affected.
the manufacturer, i-sens inc, has initiated a voluntary recall through its distributor, bioscan ltd.
according to bioscan ltd, there were 150 bgm of the affected lot imported to hong kong and 106 bgm to macao respectively.
dh has notified the health bureau of macao of the recall.
users should not use the blood glucose meters of the affected lot and seek advice from their doctors.
the department has not received any report of adverse events arising from this issue.
dh will closely monitor the recall.
the spokesman said people using the meters concerned should contact the company by calling its hotline (3589 6670) during office hours for replacement.
ends/thursday, april 23, 2009.