U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, isokinetic testing and evaluation - Product Code IKK
Causa
Review of dhrs revealed that hipot, continuity, load and friction re-testing was not completed on these devices during manufacturing.
Acción
Medx began contacting its consignees December 30, 2013, to schedule testing on the devices at their facility. The technician has been scheduled to complete required testing of these devices in the field.
For questions regarding this recall call 322-351-2005.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Exerciser, measuring - Product Code ISD
Causa
Review of dhrs revealed that hipot, continuity, load and friction re-testing was not completed on these devices during manufacturing.
Acción
Medx began contacting its consignees December 30, 2013, to schedule testing on the devices at their facility. The technician has been scheduled to complete required testing of these devices in the field.
For questions regarding this recall call 322-351-2005.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Wheelchair, powered - Product Code ITI
Causa
If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. smoking, sparking, burning or fire may occur if a wire is repetitively pinched at the same place.
Acción
The firm initiated the recall on 01/16/15 by sending a notification letter to customers through the mail. Communication was sent to providers to contact consignees via mail return receipt to inform them of the recall. Recall notification included a Provider letter, Consumer letter, Provider Response card, Unit Disposition form and tracking sheet and the Wiring guide. The notification instructed the provider to visually inspect all potentially impacted chairs. Not all potentially impacted chairs are expected to have improperly routed and secured wires.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Wheelchair, powered - Product Code ITI
Causa
If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. smoking, sparking, burning or fire may occur if a wire is repetitively pinched at the same place.
Acción
The firm initiated the recall on 01/16/15 by sending a notification letter to customers through the mail. Communication was sent to providers to contact consignees via mail return receipt to inform them of the recall. Recall notification included a Provider letter, Consumer letter, Provider Response card, Unit Disposition form and tracking sheet and the Wiring guide. The notification instructed the provider to visually inspect all potentially impacted chairs. Not all potentially impacted chairs are expected to have improperly routed and secured wires.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Wheelchair, powered - Product Code ITI
Causa
If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. smoking, sparking, burning or fire may occur if a wire is repetitively pinched at the same place.
Acción
The firm initiated the recall on 01/16/15 by sending a notification letter to customers through the mail. Communication was sent to providers to contact consignees via mail return receipt to inform them of the recall. Recall notification included a Provider letter, Consumer letter, Provider Response card, Unit Disposition form and tracking sheet and the Wiring guide. The notification instructed the provider to visually inspect all potentially impacted chairs. Not all potentially impacted chairs are expected to have improperly routed and secured wires.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Walker, mechanical - Product Code ITJ
Causa
The caster may separate completely from the device frame causing injury to user.
Acción
The firm, Roscoe Medical, issued a "URGENT RECALL NOTICE-Timely Response Required" Quarantine Communication to customers between 09/08/2014 and 09/10/2014. The notice identified affected products as 30194, serial number range MH140407092MH140407291, the problem and actions to be taken. The customers were instructed NOT to use this product and to destroy any affected product that may be in their inventory/control; immediately complete and return the attached Recall Response Form/Certificate of Destruction to Roscoe Medical- "Transport Rollator Recall" within 15 days of receipt of the recall notification via fax to (440) 572-4261 or email: corporate@roscoemedical.com, even if you do not have any affected product; and notify your customers immediately of this product recall.
Should you have any questions, contact Roscoe Medical Customer Support at (800) 376-7263 Monday-Friday 8:00 am EST - 5:00 pm EST.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Heating Pad - Product Code IRT
Causa
Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
Acción
Press release issued on 2/9/07 instructing consumers to return the product to store of purchase or Homedics. Retail stores notified via recall letter issued on 2/9/07. Retail stores are being instructed to accept returns and to post placards to notify customers of the recall.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Heating Pad - Product Code IRT
Causa
Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
Acción
Press release issued on 2/9/07 instructing consumers to return the product to store of purchase or Homedics. Retail stores notified via recall letter issued on 2/9/07. Retail stores are being instructed to accept returns and to post placards to notify customers of the recall.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Heating Pad - Product Code IRT
Causa
Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
Acción
Press release issued on 2/9/07 instructing consumers to return the product to store of purchase or Homedics. Retail stores notified via recall letter issued on 2/9/07. Retail stores are being instructed to accept returns and to post placards to notify customers of the recall.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Heating Pad - Product Code IRT
Causa
Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
Acción
Press release issued on 2/9/07 instructing consumers to return the product to store of purchase or Homedics. Retail stores notified via recall letter issued on 2/9/07. Retail stores are being instructed to accept returns and to post placards to notify customers of the recall.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Notas adicionales en la data
Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
Causa
In some cases during the use of some atar™ reusable extension cables, the cables was separating from the connector at the proximal end. the analysis of the returned devices revealed that the connector and wire separation was attributed to a fracture of the conductor cable most likely caused by extensive use of the reusable cables beyond the recommended maximum amount of 3 times. this event resulted in cable malfunction, causing interruption of the pacing system.
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.
Italian data is current through August 2018. All of the data comes from Ministero della Salute (Health Ministry), 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 Italy.
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland.
Notas adicionales en la data
Advice regarding a device removal. 3rd Party Publications
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
Safety alert on shoulderflex massager after assessing a medical device safety alert issued by the us food and drug administration (fda) on a personal massager with the brand name “shoulderflex” distributed in the us by a company called king international, the department of health (dh) urges the local community to stop using it because of its association with strangulation or other severe injuries.
a dh spokesman remarks that the shoulderflex massager is designed for home use to provide deep tissue massage to the neck, shoulder and back while the user lies on a flat surface.
"through the department's medical device surveillance scheme, we learnt that there were a few reports of either death or near-strangulation associated with shoulderflex massager in the us. according to the information available, the incidents were likely to occur when hair, clothing or jewelry became caught in the device, especially those pieces which rotated during use," the spokesman explains.
the spokesman states that the department is very concerned as the health risks could be serious even if not fatal.
"thus, in spite of the facts that the devices were mainly sold at stores or online in the us and not known to be on sale here in hong kong, nor has dh received any related notification, given the amount of travelling between the two places and also the popularity of internet trading, we consider it necessary to inform our public of the news and also advise for immediate suspension for the occasional owners," the spokesman deliberates.
finally, the spokesman adds that to be prudent, disposal of the device by owners should be in pieces so as to avoid use after reassembling.
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
Medical Device Safety Alert
Causa
Medical device safety alert: atar extension cable
the food and drug administration (fda), united states has posted a medical device safety alert concerning atar extension cable, reusable and disposable models, manufactured by oscor.
during the use of some atar extension cables, the cable was separating from the connector at the proximal end. the analysis of the returned devices revealed a change in the manufacturing sequence attributed to the connector and wire separation, causing a fracture of the conductor cable from extensive use. this event resulted in cable malfunction, causing interruption of the pacing system.
according to the manufacturer, they received a total of 66 complaints related to that failure mode, of which 5 resulted in patient injuries. no deaths were reported; however the risk for possible injury is a concern if the cable separates during use. for pacing dependent patients, an interruption of pacing system could result in serious injury or death if not detected. continuous monitoring is required.
product recall is on-going.
for details, please refer to the fda websites:
https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm566006.Htm
https://www.Fda.Gov/safety/recalls/ucm566001.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 07 july 2017.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Potential scenario where an internal potentionmeter wiper could become disconnected due to extensive wear on a certain number of assembled devices. if this were to occur the device could continue to drive forward at a slow speed of 2.4 mph and the only way to stop the device would be by turning off the main ignition key.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
During the use of some atar extension cables the cable was seperating from the connector at the proximal end. analysis revealed that the connector and wire separation was attributed to a fracture of the conductor cable malfunction causing interruption of the pacing system. the cause for the failure are attributed to a combination of manufacturing process and field misuse of the cables.
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
Invacare has recently identified a potential pinch point affecting the wiring of the listed power wheel chairs. there is a possibility that if the slack in the wires is not routed and secured correctly, and with flexing of the back pan under the user’s weight, the headrest knob or clamp bracket may pinch, damage or cut the wire creating a hazard. smoking, sparking, burning or fire may occur if any wire in this area is repetitively pinched, at the same location, over a period of time. not all impacted chairs are expected to have slack in the wiring that is not routed and secured correctly. invacare has received one complaint and there have not been any reported events involving injury associated with this issue.
Acción
Dealers are advised to identify wheelchair owners and notify them of this issue and proposed actions using the consumer letters provided by Invacare. Dealers are also advised to contact their respective customers to schedule an appointment to inspect the potentially impacted power wheelchair as soon as possible. A visual inspection of the wiring shall be conducted for each impacted chair and where required the wiring will be (corrected) routed and secured in accordance with the Power Wheelchair Wiring Guide provided to dealers. For more details, please see http://www.tga.gov.au/alert/invacare-tdx-and-storm-series-power-wheelchairs . This action has been closed-out on 18/08/2016.
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 ge healthcare internal quality inspection has found that the power cord connecting directly to the t2100 and t2000 treadmills may not have been assembled according to specifications. if the power cord was improperly assembled and a separate secondary electrical fault condition exists (e.G., a frayed extension or power cord touching the treadmill chassis), this could possibly result in an electrical shock to the patient or operator. there have been no reported incidences of the treadmill power cord leading to an electrical shock of a patient or operator at this time.
Acción
GE Healthcare is instructing customers to continue to perform the routine maintenance specified in the T2100 T2000 Service Manuals. This includes the leakage tests performed after each monthly internal cleaning, as specified in the T2100 and T2000 Service Manuals. A GE Healthcare Service Representative will contact customers to arrange a correction. This action has been closed-out on 15/08/2016.
Data from Andorra is current through November 2018. All of the data comes from Health Andorra, 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 Andorra.