BEUDAMED
    FDA Recall Terminated

    Accessory Head Rest for Alphastar Operating Tables

    Recall: Z-0161-2009 · Initiated September 26, 2008

    Recall

    Recall Number
    Z-0161-2009
    Event Number
    49545
    Firm
    MAQUET Inc.
    FEI Number
    3008355164
    Product Code
    FQO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 26, 2008
    Posted
    October 16, 2008
    Terminated
    April 16, 2009
    Address
    1140 Us Highway 22, Ste 202, Bridgewater, NJ, 08807-2958

    Description

    Accessory Head Rest for Alphastar Operating Tables

    Reason

    During installation or cleaning there is a risk of crushing the finger by handling the head rest in the area of the gas strut while simultaneously actuating the release lever.

    Action

    Urgent Device Correction letters were sent beginning September 26, 2008 via Fed Ex. Letters identified the potential for finger crush in conjunction with the head rest. Proper operating instructions are provided as well as a warning sticker to be applied to the head rest indicating proper positioning. All letters included a customer response form to be completed by each institution. Information requested is: that device correction letter has been read and instructions followed; that the corrected operating instructions have been received; that the warning sticker has been properly placed on the headrest, or that they do not have the head rest identified in the device correction letter. Questions should be addressed to USA Maquet Inc at 1-888-627-8383 #1.

    Distribution

    Nationwide Distribution

    Quantity

    88 units in US; 1884 units worldwide