Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Getinge have identified a possible water leakage on limited washer disinfectors of model type wd15. if this issue occurs, both an acoustic and visual alarm ("a03 over flow co" on the machines display) will be present. this leakage may take place during operation in the last part of the cleaning and disinfection cycle. the leaking water has not been processed through the machine and from investigations it does not make contact with critical electrical components of the washer.If the issue is left unattended, there can be a leakage of cold water out from the water supply to the machine (up to 2 l/min). if users do not respond to the alarm, there may be a significant amount of water on the floor which may result in a person falling and acquiring an injury. there is also a risk for property damage from the water leak.To date, no injuries have been reported as a result of this issue.
Acción
Getinge are advising they are investigating this issue and will provide a solution as soon as it becomes available.
In the interim, users may continue to use the washer, provided that the machine is not left unattended.
Users should react to device alarms immediately.
If an alarm *A03 OVER FLOW CO* is activated, users are advised to do the following;
1. Switch off the main switch;
2. Close shut off valves in the water supply lines; and
3. Contact a service technician.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Philips have found two potential issues that may result in the subframe of the table top becoming free floating and causing unintended, horizontal motion. the two potential issues are:1. service latch may not be properly secured;2. service latch threaded rod may be fractured.There is a risk of serious injury to the patient and operator/technician as a result of the table top free floating. for the patient:· there is a potential for disconnection or movement of invasive medical devicesfor the operator/technician:· there is a potential for pinch point on the subframe; and a potential for entrapment between the table and the gantry if the operator/technician stands between them to shift the patient forward.
Acción
Philips is advising their customers to stop using the system if horizontal free-floating couch motion is experienced during normal clinical use. The threaded rob will be replaced in all affected devices. This action has been closed-out on 12/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Philips have found that if the service latch is not properly secured during servicing of the device, the table top's subframe becomes free floating causing unintended horizontal motion during use. there is a risk of serious injury to the patient and operator/technician as a result of the table top free floating. for the patient: - there is a potential for disconnection or movement of invasive medical devices such as i.V.’s, tracheostomies, and surgical drains for the operator/technician: - there is a potential for pinch point on the subframe; and - a potential for entrapment between the table and the gantry if the operator/technician stands between them to shift the patient forward.
Acción
Philips is advising their customers to contact their Field Service Engineer, if horizontal free-floating couch motion is experienced. This action has been closed-out on 11/04/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Leica biosystems recently became aware that the affected product does not function as intended up to the expiry date on the product labelling. this was detected through stability monitoring carried out by leica biosystems. there is a link between the age of the product and staining intensity.
Acción
Leica is requesting their customers to destroy any unused reagent from lot 24963 and confirm that the affected product is no longer in use.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
A software communication failure on the heartstart xl+ that occurs during an automated ready-for-use test or at turn-on may lock the user out of clinical mode, which may delay therapy. the communication error can trigger a false failure condition - error code 1:34 "equipment disable: therapy". if the user is locked out of clinical mode, a delay in therapy may occur, which could pose a risk for patients.
Acción
Philips is providing a software update to correct the issue. End users are advised while awaiting the software upgrade for the affected device users may continue to use the HeartStart XL+ unless the device exhibits a Red X, presents an audio chirp and displays the user message: “Equipment Disabled: Therapy”. This is an indicator that the device self-test has detected the problem and is not ready for use. In the case the problem cannot be resolved by running Op-Check, users should identify a readily available backup defibrillator to use in the event the affected HeartStart XL+ exhibits the communication failure. This action has been closed-out on 01/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The affected part and lots numbers of the "orbital rim plate" have been mislabelled as "orbital floor plate". the mislabelling non-conformance may result in user dissatisfaction, but is not likely to impact the patient.
Acción
DePuy Synthes is notifying their customers of the correct label information for the Orbital Rim Plate and Orbital Floor Plate.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
It was found that for software v5.1.0001-0007 used in workstation (aws), which is a component of fujifilm digital mammography system, when image enhancement processing is performed on the exposed image with an option function during biopsy, the screen may not return to the original image. depending on the enhancement parameter, the calcification may seem unclear compared to the original image. therefore, there is a potential that the tip of needle cannot reach the desired biopsy area. furthermore, after collecting the target sample, it may be difficult to ascertain whether the necessary calcification part has been properly extracted. due to these reasons, the occurrence of this issue may precipitate that a re-examination might be necessary. this image processing is an option for biopsy and does not affect other normal exposures.
Acción
Customers are advised to not perform image enhancement during Biopsy. In the case that a calcification becomes unclear due to enhancement processing, select the weakest enhancement processing or redisplay the image on the 1st monitor by right-clicking. FUJIFILM service personnel will contact the affected facility to arrange for a software update as a corrective measure.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Stryker has become aware that gravity sterilisation parameters provided in the 12 instrument sterilisation reprocessing guide (1000400920 rev d) did not fully consider all worst-case scenarios during validation testing. although, to date there have been no reported events to stryker of infection as a result of the use of the sterilization parameters previously provided with these trays, there is a remote possibility for infection.
Acción
End users are advised to discard any old Instructions for Use (IFU) for 12 Instrument Sterilization Tray(s) that make reference to the gravity steam sterilization method (121oC for 30 minutes). New IFU can be downloaded from www.stryker.com/12instrumenttray
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The “switch user” feature is an option in windows 7 that allows another user to open a new session with his user account without requiring the previous user to log out of the existing session. it has been discovered that running the same synapse cv client application under more than one windows user account simultaneously may cause outbound hl7 reports with incorrect data to be sent to emr. there is the potential that patients’ medical records may be altered as a result of utilizing this windows 7 function through the unintentional modification of the outbound hl7 files. this issue does not occur if individual users logout of windows 7.
Acción
Fujifilm does not support the use of the “Switch User” function in Windows 7 with Synapse CV. The function should be disabled on Windows 7 workstations that operate the Synapse CV application. There are several options to allow multiple users on a workstation and, if required, Fujifilm Customer Support will assist users with determining which option is best suited for each facility.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Ortho clinical diagnostics (ocd) determined that, due to a software timing issue, a sample tube carrier being released in the bypass module may not be detected, potentially resulting in the next sample to be metered not advancing for processing. no error message will be posted if this occurs. the bypass module will stop processing samples indefinitely until an operator detects the issue and intervenes.
Acción
Ortho-Clinical Diagnostics will provide a resolution for this issue in a future software version. In the interim, end users are requested to routinely monitor the Bypass module for stoppage due to the software timing issue. This action has been close-out on 11/02/2016.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 recall data from the U.S. and Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The following issues may occur when using the stress echo feature:- shorter-than-expected clips may occur when using systolic-only captures with heart rates at approximately 120bpm (beats per minute) and higher. this computational error may occur at any heart rate; but the system produces a smaller error for lower heart rates. the issue may also cause the system to change from systolic-only captures to full beat (r-r).- intermittently, some post-exercise clips may not be captured during continuous capture acquisition. - post-exercise clips marked for deletion (unselected clips) may be restored to the study after cycling power to the system. the potential risk to the patient may be a repeated stress echo study.
Acción
A software update will be provided to correct this problem.
End users are advised to avoid the potential risks associated with this issue by:
- Discontinue use of the stress echo feature with software version 3.5
- For studies acquired with the systolic only captures, review all patient studies on exams performed after the software revision 3.5 was installed.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Ge healthcare has recently become aware of a potential safety issue due to gas sampling pump failure associated with the compact airway gas modules. loosening of the gas sampling pump hex screw in the module pump may lead to pump failure that may cause loss of respiratory airway gas parameter monitoring. if this issue occurs, the monitor will show an alarm note on monitor screen of either "low gas sample flow" or "check sample gas out".
Acción
GE Healthcare will implement a correction for the affected modules. If the monitor is showing an alarm of “Low gas sample flow” or “Check sample gas out”, users are advised to check the following before continued use:
1. Check the water trap is not full or occluded. If full or occluded, empty/change the water trap.
2. Check gas sampling adapter at patient airway is not occluded.
3. Check sample line is not occluded. If occluded, change new gas sampling line.
4. Check gas exhaust outlet is not occluded. Ensure there is no blockage preventing the sample gas out flow to scavenging.
If the above actions do not remove the alarm message(s), it may be due to the issue described above. Users are advised to remove the equipment from use and contact technical support or local service representative. This action has been closed-out on 02/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The manufacturer, raysearch laboratories has identified a problem with the computation of roi voxel volumes for cases where the ct has variable slice spacing. the dose grid volumetric representation of an roi can be wrong. this affects all dose-volume properties for such rois, including dvh, dose statistics, clinical goals and constraints or objective functions. furthermore, if material override rois are used, or if the external is not represented by contours, the bug can trigger an error in the 3d dose distribution. the problem has, to the best of raysearch laboratories' knowledge, not caused any patient mistreatment.
Acción
This problem will be resolved in a future release of RayStation. Customers wanting to continue to use variable slice spacing should contact their Support representative for workarounds. RayStation 4.0.3 may not be used with CT data where variable slice spacing has been used, until a workaround has been provided. For now, applicable CT scanners should, if possible, be configured to uniform slice spacing. If there are patient plans with variable CT slice spacing being used for treatment, please contact Support representative for assistance on identifying if the problem is present and workarounds. The database of patients planned with RayStation 4.0.3 should be analysed for identification of potential errors in dose analysis for completed treatments. This action has been closed-out on 01/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Frensenius kabi initiated a software upgrade due to three incident reports concerning three different issues:injectomat and volumat pumps:1. the pdms from picis implemented an unexpected high number of connection/disconection requests resulting in a "watchdog" error message.2. if the user configured the vigilant drug lib software with a drug with fixed dilutions, the selection on the pump of this drug as a first step then followed by the selection of 'drug x in ml/hr' as a second step could result in the display of a technical error. concerning injectomat pumps: 3. in a high vibration environment, for example close to the warming device, the syringe installation check sensor signal can be unstablepotentially triggering a technical error (n-deg 23).This action was undertaken prior to notifying the tga.
Acción
Fresenius Kabi has updated the software of all affected Injectomat and Volumat devices.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Medtronic has identified the development of high resistance on internal electrical connector contacts due to oxidation over time. due to the unpredictable nature of the oxidation process on multiple electrical contacts, this issue may result in one or more of the following: • pacing rate outside of the intended setting, potentially including a sudden increase in pacing rate up to the maximum setting of 180 ppm. • output amplitude or sensitivity outside of intended setting. • pace, sense, or low battery led indicators not lighting during power on or reset functions. • rapid atrial pacing (rap) display with intermittent functionality. • intermittent functionality of the on/off and rap control buttons.
Acción
Medtronic recommends that the following actions be taken when using a potentially affected Model 5348 EPG:
• Monitor the EPG function and patient’s heart rhythm continuously while the EPG is in use to ensure it is operating properly and delivering appropriate therapy to the patient.
• If any malfunction is observed with a 5348 EPG, ensure the patient’s condition is stabilized, discontinue use of the Model 5348 device and contact your Medtronic representative.
During the design and development of new models, Medtronic identified that a service life of five years is most appropriate for an External Pulse Generator. Therfore, Medtronic is advising customers that they will no longer provide standard servicing of EPGs (calibration, physical inspection or repair) that are more than five years old including these potentially affected 5348 EPGs. Continued use of the device will require end users to perform the relevant maintenance procedures to ensure safe and effective operation of the devices.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The manufacturer have received reports about single syringes of these lot showing more than usual jerky extrusion behaviour. in one case this led to a fluid ejection from the syringe in front of a hygienist when pushing harder on the plunger rod outside the mouth. if uncontrolled fluid ejection from the syringe occurs, especially the dental patient could be exposed to the gel reaching the mucosa, the face or even the eyes causing irritation, chemical burns and blistering of the tissues which is a medically reversible condition.
Acción
Customers are advised to search their inventory and immediately quarantine any GLUMA Desensitizer PowerGel stock with the affected lot numbers. Stop using the affected products and return the product to the distributor. This action has been closed-out on 11/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
A review of the medtronic internal returned goods procedures showed that there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage. although there have been no reports of issues related to package sterile barrier damage, medtronic is recalling all potentially affected devices as a precaution.
Acción
Customers will be contacted by a Medtronic representative who will make arrangements visit the facility for the collection and return of any of the affected products, as appropriate. During this visit, Medtronic will arrange to replace the goods free of charge. This action has been closed-out on 11/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
This recall action has been initiated by ortho-clinical diagnostics, inc. (ocd) due to the potential for biased results when a multiple window (mw) code is associated with results generated by the vitros® systems listed. a mw code is a flag/error code generated when a potential issue with the results calculation is detected. this code does not suppress the sample result. a mw code is a flag/error code generated when a potential issue with the results calculation is detected. this code does not suppress the sample result.
Acción
Ortho-Clinical Diagnostics (OCD) will resolve this issue in a future software release. To assist in the interim OCD is providing a procedure for reviewing VITROS chemistry results and MW codes. This action has been closed-out on 11/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Investigations by the manufacturer oxoid limited, part of thermo fisher scientific, have confirmed that cartridges within this batch may contain individual discs not impregnated with sufficient antibiotic. continued use of this lot could result in false indication of resistance.
Acción
End users are requested to inspect their stock for affected units. Affected units are to be removed from further use. The requirement for the review of patient results should be determined by the laboratory director.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
An internal assessment of product performance, including a review of customer feedback, has confirmed that flexi-seal control faecal management system is not meeting performance requirements for this product. specifically, the auto-valve has not been consistently performing relative to the inflation and deflation of the device’s retention balloon. in the event that the auto-valve does not perform properly related to inflation and deflation of the device’s retention balloon, there is the potential that medical intervention may be necessary. in accordance with the instructions for use supplied with the flexi-sealtm controltm faecal management system, the following events could occur:- leakage of stool around the device, and peri-anal skin breakdown;- rectal/anal bleeding due to pressure necrosis or ulceration of rectal or anal mucosa;- perforation of the bowel.
Acción
End users are advised to stop the use of all affected devices and return all affected products to their distributor for credit or replacement with unaffected product.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Causa
Through customer complaints, hospira has become aware of customers using the incorrect size receptal liners with their receptal canisters, e.G., 2l liner or 3l liner with a 1.5l canister, which has resulted in a report of one death to date. there have been no reports of death or serious injury in australia. it is possible that if an incorrectly sized liner is used with a different size canister the lid may not fit and the vacuum/suction will not be sufficient and/or consistent. hospira advises users to not use incorrectly sized receptal liners with receptal canisters. all receptal liner and canister list numbers are affected by this action.
Acción
Hospira is advising hospitals to only use the correct size liners are used with the corresponding canister and to ensure that the liner is fully extended in the liner.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Heartware has seen an increase in reported heartware system power management complaints related to both premature battery failure and routine battery handling. premature or unrecognised deterioration of battery capacity or lapses in recommended power management pose a risk to the patient and, although rare, may result in serious injury or death. this action is intended to provide patients and healthcare providers with information to recognise batteries with less than two hours of run time, re-emphasise instruction on actions to take when battery alarms occur and reinforce proper power management. early recognition of premature battery depletion, patient training and close attention to recommended power management practices are crucial to reduce patient risk.
Acción
HeartWare is providing information to assist patients and health professionals to monitor battery performance and recognise abnormal behaviour. Health professionals are advised to reinforce the recommended practices for early detection of abnormal battery behaviour and effective power management with their patients. The customer letters identifies the steps to verify that all patients with the HeartWare Batteries are managing their power sources in a safe manner and that batteries are handled in accordance with the Instructions for Use. HeartWare is also advising that complaints will continue to be closely monitored to ensure that the HeartWare System functions as intended and to assess the effectiveness of this field correction. HeartWare will continue to investigate prematurely depleting batteries and will take additional actions as appropriate.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Microport orthopedics inc. have confirmed that some path thread cup adaptors may become difficult to disengage once impacted intra-operatively. path thread cup adaptors are surgical instrumentation used during hip surgery.
Acción
Surgical Specialties is requesting their customers to inspect their stock and return any product from the affected lots immediately.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Drager has become aware of cases where prior to the use of the disposable ventstar oxylog 2000 ventilation hoses, adhesive residue the size of a finger nail was found loose in the hose or the packaging around the hose; had teh hose been used with the residue in place it may have entered the patient's lungs.
Acción
Draeger is advising their customers to not use the hose system from the affected batches and to contact customer service to arrange for recovery and replacement.