Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractabl

FDA device recall Z-2130-2023 · posted 2023-07-12 · Open, Classified

Recall details

Recalling firm

Stryker Medical Division of Stryker Corporation

Reason for recall

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.

Action taken

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 productfieldaction@stryker.com. 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.

Root cause

Process control

Status

Open, Classified

Product code

FPO

Quantity affected

1,980 cots

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Switzerland, United Kingdom.

Date initiated

2023-05-24

Date posted

2023-07-12

Location

Portage, MI