BEUDAMED
    FDA Recall Open, Classified

    ProCuity bed series, model number 3009, item number: 3009PX-LE-450.

    Recall: Z-0428-2024 · Initiated August 30, 2023

    Recall

    Recall Number
    Z-0428-2024
    Event Number
    93317
    Firm
    Stryker Medical Division of Stryker Corporation
    FEI Number
    1831750
    Product Code
    FNL
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 30, 2023
    Posted
    December 1, 2023
    Address
    3800 E Centre Ave, Portage, MI, 49002-5826

    Description

    ProCuity bed series, model number 3009, item number: 3009PX-LE-450.

    Reason

    Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

    Action

    A customer notification was sent October 20, 2023 via FedEx. Users are to (1) Locate affected units and identify the address where they can be serviced. (2) Return the business reply form by fax +1 269 488-8691 or email to [email protected]. Upon receipt of the completed business reply form, Stryker will contact you to arrange a time to complete the required electrical tests. (3) Forward notification to any new user/location and advise Stryker of the new address or device status if disposed of or obsolete using the reply form. Address questions or concerns to Customer Service at +1 800 327-0770 Monday through Friday from 8:00 a.m. to 6:00 p.m. ET.

    Distribution

    Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.