Recall Z-2130-2023 ยท FPO Stretcher, Wheeled
Stryker Medical Division of Stryker Corporation
Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 6507
| Date | Jul 12, 2023 (initiated May 24, 2023) |
| Status | Open, Classified |
| Reason | Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or lowering the cot, cot tip, or erratic or unintended motion. |
| Root cause | Process control |
| Action | Stryker issued Urgent Medical Device Correction Letter on May 24, 2023 via Fed'X. Letter states reason for recall, health risk and action to take: 1. Locate the units listed on the attached business reply form and identify the address where they can be serviced. 2. Review and follow the required customer actions set forth in Appendix A to ensure the unit continues to operate safely until the correction can be performed. If any of the issues listed are present, remove the unit from service and contact Tech Support to request a service visit. 3. Return the enclosed business reply form to confirm |
| Quantity | 1,980 cots |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Switzerland, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.