BEUDAMED
    FDA Recall Open, Classified

    Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001

    Recall: Z-1256-2023 · Initiated February 1, 2023

    Recall

    Recall Number
    Z-1256-2023
    Event Number
    91716
    Firm
    Stryker Medical Division of Stryker Corporation
    FEI Number
    1831750
    Product Code
    FPO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 1, 2023
    Posted
    March 15, 2023
    Address
    3800 E Centre Ave, Portage, MI, 49002-5826

    Description

    Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001

    Reason

    Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement while loading/unloading or transport.

    Action

    Stryker issued Urgent Medical Device Correction letter dated 2/1/23. Letter states reason for recall, health risk and action to take: 1. Locate the units listed on the attached business reply form and remove them from service until repairs are complete. 2. Return the enclosed business reply form to confirm receipt of this notification by fax +1 269 488 8691 or email [email protected]. 3. Stryker will contact you to arrange for the modification/repair of your Power-PRO 2. 4. If you have loaned or sold or disposed of 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. Questions or concerns, contact Customer Service at +1 800 327 0770 Monday through Friday from 8:00 a.m. to 6:00 p.m. ET.

    Distribution

    US Nationwide distribution in the states of NY, VA.

    Quantity

    4 units