Device Recall Stryker Secure II Bed 의 리콜

Recall

61054

Class 2

Z-1354-2012

2012-03-12

2012-03-30

Terminated

United States

2013-08-29

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107182

Stryker medical has determined that units manufactured between september 1, 2004 through november 30, 2007, did not receive updated preventive maintenance information. (failure to maintain the bed brakes including the brake plate kits, may result in reduced brake holding force. reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical int.

Stryker Medical sent an Urgent-Medical Device Correction letter dated March 12, 2012 to all consignees. The letter identified the affected products, problem, updated preventive maintenance information and requested the following immediate actions: 1) Locate the beds listed in this notice, 2) Ensure that the brakes are holding properly, 3) If the brakes are not holding, contact Stryker (1-800-327-0770, option 4) to order the maintenance parts, 3) Continue to periodically inspect brake functionality, as noted on enclosed preventive maintenance schedule/checklist, 4) Order replacement brake components, as needed, 5) Return the enclosed post card to confirm receipt of this notification, 6) If you have loaned or sold any of the beds listed in this letter, please, forward a copy of this notice to the new users and advise us of their new location, 6) If you have disposed of any of the beds and they are no longer in use, please, advise us of their obsolescence by providing us with their serial numbers. For questions or concerns, please, contact Sandy Cliche at 269-389-6025.