BEUDAMED
    FDA Enforcement Class II Ongoing

    ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4

    Recall: Z-2271-2024 · Reported July 17, 2024

    Enforcement

    Recall Number
    Z-2271-2024
    Event ID
    94740
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Getinge Usa Sales Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 17, 2024
    Initiation Date
    May 29, 2024
    Classification Date
    July 5, 2024
    Address
    1 Geoffrey Way, N/A, Wayne, NJ, 07470-2035, United States

    Description

    ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4

    Reason

    The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational failure.

    Code Info

    Model Number/Part Number: 113322B4; UDI/DI: 04046768040007; Serial Numbers: 3018 through 3078, 3080 through 3086, 3088 through 3089, 3095 through 3097.

    Distribution

    Domestic: KY, NC, NY, VA. International: Australia, Bulgaria, Croatia, Czech Republic, Denmark, France, Greece, Hong Kong, Ireland, Israel, Japan, Jordan, Kuwait, Mexico, New Zealand, Norway, Poland, Romania, Saudi Arabia, South Africa, Spain, Switzerland, Thailand, United Arab Emirates, United Kingdom.

    Quantity

    73 units