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
Recall
- Recall Number
- Z-2130-2023
- Event Number
- 92499
- Firm
- Stryker Medical Division of Stryker Corporation
- FEI Number
- 1831750
- Product Code
- FPO
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- May 24, 2023
- Posted
- July 12, 2023
- Address
- 3800 E Centre Ave, Portage, MI, 49002-5826
Description
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
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.
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 receipt of this notification by fax +1 269 488 8691 or email [email protected]. 4. Stryker will be initiating a correction for all affected Power-PRO 2 units and will contact customers to schedule device corrections once the correction is ready for implementation. The company will provide customers with updated information when it is available. 5. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form. 6. If you have disposed of any of these units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial number in the space provided on the business reply form. If you have any questions or concerns, contact Technical Support at 1 800 787 9537 option 2 Monday through Friday from 8:00 a.m. to 6:00 p.m. ET.
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Switzerland, United Kingdom.
1,980 cots