Class 2 Device Recall PowerPRO 2

• Date Initiated by Firm: May 24, 2023
• Date Posted: July 12, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2130-2023
• Recall Event ID: 92499
• Product Classification: Stretcher, wheeled - Product Code FPO
• Product: 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
• Code Information: Model: 650700000000 UDI-DI: 07613327504460; Model: 650705550001 UDI-DI: 07613327559118; Model: 650705550002 UDI-DI: 07613327559125; Cots shipped between February 11, 2022 and February 1, 2023 Serial Numbers: 2112001485 2112001488 2112001489 2112001490 2112001491 2112001492 2112001493 2112001494 2112001495 2112001496 2112001501 2112001503 2112001504 2112001508 2112001509 2112001510 2112001511 2112001512 2112001513 2112001514 2112001515 2112001516 2112001517 2112001518 2112001519 2112001520 2112001521 2112001522 2112001523 2112001524 2112001525 2112001526 2112001527 2112001528 2112001529 2112001530 2112001531 2112001532 2112001533 2112001534 2112001535 2112001536 2202000473 2202000474 2202000475 2202000476 2202000477 2202000478 2202000479 2202000480 2202000481 2202000482 2202000483 2202000484 2202000485 2202000487 2202000488 2202000489 2202000490 2202000491 2202000492 2202000797 2202000798 2202000799 2202000800 2202000801 2202000802 2202000803 2202000804 2202000805 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• Recalling Firm/ Manufacturer: Stryker Medical Division of Stryker Corporation; 3800 E Centre Ave; Portage MI 49002-5826
• For Additional Information Contact: SAME; 269-389-8306
• Manufacturer 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.
• FDA Determined 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 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.
• Quantity in Commerce: 1,980 cots
• Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Switzerland, United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.