BEUDAMED
    FDA Recall Terminated

    HANAULUX 2004 IXL cupola, P/N: 56076868 Intended to provide visible illumination for the surgical field or for the examination of the patient.

    Recall: Z-0182-2010 · Initiated October 7, 2009

    Recall

    Recall Number
    Z-0182-2010
    Event Number
    53499
    Firm
    MAQUET Inc.
    FEI Number
    3008355164
    Product Code
    FTD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 7, 2009
    Posted
    November 12, 2009
    Terminated
    June 4, 2012
    Address
    1140 Us Highway 22, Ste 202, Bridgewater, NJ, 08807-2958

    Description

    HANAULUX 2004 IXL cupola, P/N: 56076868 Intended to provide visible illumination for the surgical field or for the examination of the patient.

    Reason

    Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm.

    Action

    Urgent Device Correction letters, dated October 7, 2009, were sent out by FedEx. The letter identified the affected products and asked customers to call 1-888-627-8383 #1, if they have any questions. The letter also provided a Technical Description along with a Customer Fax Response form. The letter stated the potential hazard and recommended precaution. If customers need additional info or have any questions they should contact their local MAQUET representative.

    Distribution

    Nationwide Distribution.

    Quantity

    3