BEUDAMED
    FDA Enforcement Class II Terminated

    Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function

    Recall: Z-2479-2021 · Reported September 22, 2021

    Enforcement

    Recall Number
    Z-2479-2021
    Event ID
    88435
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arjohuntleigh Magog, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 22, 2021
    Initiation Date
    March 4, 2021
    Classification Date
    September 16, 2021
    Termination Date
    January 12, 2024
    Address
    2001 Tanguay St, N/A, Magog, N/A, N/A, Canada

    Description

    Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function

    Reason

    The spreader bar can disconnect from the scale bottom attachment.

    Code Info

    All units of Model 700-00536: Class III 454 kg scale and Model 700-00526: 454 kg scale

    Distribution

    Distribution in US - AZ, CA, CO, IL, LA, MA, MI, MO, OH, PA, WA

    Quantity

    62 units