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.
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.
Notes supplémentaires dans les données
Press release
Cause
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.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
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.
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.
Notes supplémentaires dans les données
Cause
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.
Action
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.
Notes supplémentaires dans les données
Cause
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.
Action
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.
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.
Notes supplémentaires dans les données
Cause
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.
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.
Notes supplémentaires dans les données
Cause
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.
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.
Notes supplémentaires dans les données
Advice regarding a device removal. 3rd Party Publications
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.
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.
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.
Notes supplémentaires dans les données
Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
Cause
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.
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.
Some units of fluro-ethyl containing the defective valve which could malfunction and spray refrigerant out from the side of the valve in addition to or instead of spraying in the normal inverted position from the product's actuator. the product can also leak coolant from the side of the valve onto the fingers of the user.
Action
A recall notification letter (Recall Notice) (dated 9/3/2008) was issued on 9/16/2008 to customers. The notice instructs customers to check their inventory for any remaining recall product and if found, return the product to the Gebauer Company. The letter also advises distributors to notify their customers and follow instructions as noted above, i.e. customers inventory their stock for recalled product and if found, return to the Gauber Company. For questions or additional information, contact Gebauer Company at 216-581-3030 (ext. 120) or 800-321-9348.
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.
Notes supplémentaires dans les données
Toddler Chair - Product Code INN
Cause
Some hip straps were assembled incorrectly by threading the buckle on the strap upside down. if a child were left unattended in spite of the warnings on the product and in the manual, a defective hip strap could loosen, allowing the child to slip down in the chair and this could create a choking hazard.
Action
On 9/12/08, Rifton Equipment began notifying the customers by phone using a phone script. This phone call notified the customers of the recall and also served as an effectiveness check that they were notified. The customers were instructed to remove the product from use until the replacement kit is received and the old strap is returned. The replacement kit contains instructions with ID codes and a place for the customer to verify that they have made the replacement as instructed. It also contains the required number of new hip straps. A verification check was sent with the replacement straps, which the customer will sign and return to the firm verifying that they have replaced the straps for the affected serial numbers. Rifton Equipment is providing the customer with return shipping labels which were sent by UPS 2nd day air. The replacement straps use black thread instead of tan thread for the sewing on the ends of the straps so that the firm can be sure that the returned straps are not the new replacement straps.
For questions or additional information, contact Rifton Equipment at 1-800-571-8198.
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.
Notes supplémentaires dans les données
Transfer Aid - Product Code IKX
Cause
Misassembled gait (transfer aid) belt.
Action
Alimed notified accounts via U.S. Postal Service (Return Receipt Requested) with a Recall Notice dated 10/30/2008 and instructs users to review their records and notify all users to whom the product may have been issued. If any of the product has been issued outside of their facility, customers are to forward the correspondence to them in it's entirety. Customers are to complete the enclosed form for return of their product (new or used) and the issuance of replacement product or credit.
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.
Notes supplémentaires dans les données
Wheelchair, powered - Product Code ITI
Cause
There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base.
Action
The firm initiated the recall by letter on 09/01/2017. The distributor/dealers were instructed as follows:
LOG INTO CORRECTION WEB PORTAL
Immediately log into www.permobilfsa.com. Log in with the following ID and Password.
CEASE DISTRIBUTION OF EXISTING INVENTORY
Please examine your inventory for the serial numbers assigned to you, cease distribution, and quarantine those chairs.
IMMEDIATELY PERFORM INSPECTION
If you have distributed these serial numbers to end users, you must immediately contact them to perform a visual inspection of the top plate assembly looking for obvious signs of cracking.
If the top plate shows no signs of cracking the wheelchair may continue to be used in accordance with the owners manual until the correction is performed.
If the top plate does show signs of cracking please inform the user that the chair cannot be used until the correction is performed. Next, log into the web portal to obtain further instructions and assistance. In these cases which are expected to be rare, we will assist with a temporary solution to keep the client mobile during the time between inspection and correction.
PERFORMING THE CORRECTION
You will be notified when repair kits are available and the process to follow to obtain the proper kit for the serial number you are correcting.
The web portal will include a template letter to send to end users explaining the hazard and the need to cooperate with this correction effort. Correction instructions and related supporting materials will also be available. We are also providing the end user with a certificate for a free light kit towards the purchase of a new Permobil power chair.
Please contact your Permobil sales representative if you have any questions regarding this correction.
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.
Notes supplémentaires dans les données
Transfer Aid - Product Code IKX
Cause
Misassembled gait (transfer aid) belt.
Action
Alimed notified accounts via U.S. Postal Service (Return Receipt Requested) with a Recall Notice dated 10/30/2008 and instructs users to review their records and notify all users to whom the product may have been issued. If any of the product has been issued outside of their facility, customers are to forward the correspondence to them in it's entirety. Customers are to complete the enclosed form for return of their product (new or used) and the issuance of replacement product or credit.
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.
Notes supplémentaires dans les données
Chair, with casters - Product Code INM
Cause
Winco mfg., llc, ocala, florida is recalling their care cliner. due to malfunctioning axles which become lose from the caster assembly. this chair is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion. recalled chairs include the following: care cliner, xl care cliner, drop arm care cliner.
Action
Winco sent an Urgent Device Recall letter dated October 1, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Replacement parts were sent out to the consignees and customers were asked to dispose of the defective casters. Any consignee not reponding by November 15, 2010, would receive an additional letter.
The firm placed a follow up phone call to the non responding consignees after two weeks.
Customers were advised to call 800-237-3377 or email customer service at customerservice@wincomfg.com with questions or concerns.
For questions or concerns regarding this recall call 352-854-2929 x 110.
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.
Otto bock healthcare products gmbh has identified a design issue through extended durability
testing where the pylon clamping mechanism has the potential to cause damage to the
pylon. when used longer than 1.45 million cycles (which represents approximately 2.3
years of use of the knee joint under heavy usage conditions), and the pylon clamp is overtightened
according to the labeled torque specification, and the patient weighs at most
125kg it may be remote that the pylon breaks, and causing the patient to fall.
there have been no failures or complaints reported directly attributed to the failure mode
collapsed pylon .
in the us market and in canada, labeling requires a condition based service at three years.
in the rest of the world, a mandatory two year service interval is specified. only the devices
in distribution in the united states and canada are affected by this action.
Action
On September 14, 2017 a letter was sent to all their consignees via 2nd day signature receipt required to customers instructing them to contact their patients and send in their devices for service within the first 2.3 years of use. The pylon clamp will be replaced at no charge. The pylon will also be inspected and replaced if necessary. The customer will be requested to complete a reply form indicating they have received the notice and intend to contact their patients to arrange for the requested service.
Customer Service: (800) 328-3458 Option 1
Loaner Service: (800) 328-3458 Option 3, then Option 1
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.
Otto bock healthcare products gmbh has identified a design issue through extended durability
testing where the pylon clamping mechanism has the potential to cause damage to the
pylon. when used longer than 1.45 million cycles (which represents approximately 2.3
years of use of the knee joint under heavy usage conditions), and the pylon clamp is overtightened
according to the labeled torque specification, and the patient weighs at most
125kg it may be remote that the pylon breaks, and causing the patient to fall.
there have been no failures or complaints reported directly attributed to the failure mode
collapsed pylon .
in the us market and in canada, labeling requires a condition based service at three years.
in the rest of the world, a mandatory two year service interval is specified. only the devices
in distribution in the united states and canada are affected by this action.
Action
On September 14, 2017 a letter was sent to all their consignees via 2nd day signature receipt required to customers instructing them to contact their patients and send in their devices for service within the first 2.3 years of use. The pylon clamp will be replaced at no charge. The pylon will also be inspected and replaced if necessary. The customer will be requested to complete a reply form indicating they have received the notice and intend to contact their patients to arrange for the requested service.
Customer Service: (800) 328-3458 Option 1
Loaner Service: (800) 328-3458 Option 3, then Option 1
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.
Otto bock health care lp has discovered that in some cases, the securing screws of the joint axes may not have been properly mounted. this can cause the axes to gradually move out of the joint and result in a risk of falling for the user.
Action
Consignees were sent on 10/28/08 a Otto Bock "Urgent: Correction Notice" letter dated October 27, 2008. The letter described the product and problem. It provided instructions if the product was in stock and instructed the consignee to contact the patients (a patient letter was provided) and to complete and return the reply card. Consignees were to contact Otto Bock at their Customer Service to request a return authorization.
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.
Notes supplémentaires dans les données
Wheelchair, Mechanical - Product Code IOR
Cause
Under certain conditions the tilt mechanism of the strollers may not function properly allowing the child to fall out if the seat belt is not fastened.
Action
Recall letters dated October 23, 2003 were sent to the consignees on 10/29/03 and 10/30/03. The letters requested that the consignees contact the firm''s Customer Service Department to report the affected units they have. The letter states that the Customer Service Department will send the consignees the necessary field modification kits and instructions to correct the problem in the units they have and have located at their customers.
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.
Notes supplémentaires dans les données
Wheelchair, powered - Product Code ITI
Cause
There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base.
Action
The firm initiated the recall by letter on 09/01/2017. The distributor/dealers were instructed as follows:
LOG INTO CORRECTION WEB PORTAL
Immediately log into www.permobilfsa.com. Log in with the following ID and Password.
CEASE DISTRIBUTION OF EXISTING INVENTORY
Please examine your inventory for the serial numbers assigned to you, cease distribution, and quarantine those chairs.
IMMEDIATELY PERFORM INSPECTION
If you have distributed these serial numbers to end users, you must immediately contact them to perform a visual inspection of the top plate assembly looking for obvious signs of cracking.
If the top plate shows no signs of cracking the wheelchair may continue to be used in accordance with the owners manual until the correction is performed.
If the top plate does show signs of cracking please inform the user that the chair cannot be used until the correction is performed. Next, log into the web portal to obtain further instructions and assistance. In these cases which are expected to be rare, we will assist with a temporary solution to keep the client mobile during the time between inspection and correction.
PERFORMING THE CORRECTION
You will be notified when repair kits are available and the process to follow to obtain the proper kit for the serial number you are correcting.
The web portal will include a template letter to send to end users explaining the hazard and the need to cooperate with this correction effort. Correction instructions and related supporting materials will also be available. We are also providing the end user with a certificate for a free light kit towards the purchase of a new Permobil power chair.
Please contact your Permobil sales representative if you have any questions regarding this correction.
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.
Notes supplémentaires dans les données
Bed, Patient Rotation, Powered - Product Code IKZ
Cause
Design control/validation deficiencies.
Action
Letter dated 10/25/2004 to Stryker Medical, own-label distributor, with instructions to remove patients from the system and return units to Gaymar.