BEUDAMED
    FDA Enforcement Class II Terminated

    Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.

    Recall: Z-0987-2019 · Reported March 13, 2019

    Enforcement

    Recall Number
    Z-0987-2019
    Event ID
    82074
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GETINGE US SALES LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 13, 2019
    Initiation Date
    January 8, 2019
    Classification Date
    March 7, 2019
    Termination Date
    June 3, 2020
    Address
    45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States

    Description

    Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.

    Reason

    The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain conditions while using the flat screen monitor holder with voltage of 100-220V.

    Code Info

    Serial Numbers 500009 500010 500011 500012 500013 500014

    Distribution

    The products were distributed to the following US states: AZ and TX.

    Quantity

    6