Recall Z-0479-2023 ยท FPO Stretcher, Wheeled
Stryker Medical Division of Stryker Corporation
Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)
| Date | Dec 14, 2022 (initiated Nov 11, 2022) |
| Status | Open, Classified |
| Reason | Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury to patients such as scrapes or bruises resulting from the cot lowering faster than expected. |
| Root cause | Under Investigation by firm |
| Action | On November 11, 2022, the firm notified affected customers via "URGENT: MEDICAL DEVICE CORRECTION" letters. Devices require servicing. Customers were instructed to locate affected units and identify the address where they can be serviced. Until servicing can be performed, customers were provided with additional instructions and precautions to follow to ensure safe continued use of the device. Return the enclosed business reply form to confirm receipt of this notification by fax +1 269 488 8691 or email productfieldaction@stryker.com. Upon receipt of the completed business reply form, Stryker |
| Quantity | 465 (403 US; 62 OUS) |
| Distribution | Worldwide Distribution: US (Nationwide) and Foreign to countries of: Australia, Canada, Netherlands, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.