BEUDAMED
    FDA Recall Terminated

    AC-powered adjustable medical beds with built-in electric DC actuators and controls.

    Recall: Z-1135-2022 · Initiated April 11, 2022

    Recall

    Recall Number
    Z-1135-2022
    Event Number
    90058
    Firm
    Umano Medical, Inc.
    FEI Number
    3009591865
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 11, 2022
    Terminated
    January 17, 2024
    Address
    230 Nilus-Leclerc Blvd, L'Islet Canada

    Description

    AC-powered adjustable medical beds with built-in electric DC actuators and controls.

    Reason

    There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.

    Action

    The firm sent out the recall notification to the consignees on 04/11/2022 via email. The letter instructs the users to avoid using the product and forward the notice to any affected users. The letter directed to the distributors instructs them to stop distribution of the product, send the notice to users of the product, and send a report to the manufacturer conforming inventory and contact information for each site that was contacted.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CA, PA, AL, GA, AZ, MN, FL, WA, OK, NY, ND, AR, MO, NC, UT, TX, WI, and the countries of Australia, Ireland, and Canada.

    Quantity

    228 units