BEUDAMED
    FDA Recall Terminated

    Alm Prismatic Surgical Light 5004 SF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures.

    Recall: Z-1154-2009 · Initiated February 23, 2009

    Recall

    Recall Number
    Z-1154-2009
    Event Number
    51297
    Firm
    MAQUET Inc.
    FEI Number
    3008355164
    Product Code
    FTD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 23, 2009
    Posted
    April 12, 2009
    Terminated
    September 29, 2009
    Address
    1140 US Highway 22 East, Suite 202, Bridgewater, NJ, 08807-2958

    Description

    Alm Prismatic Surgical Light 5004 SF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures.

    Reason

    The screws holding the Prismatic triple surgical lights may break due to dynamic multidirectional bending stress. The firm has received one complaint report.

    Action

    An "Urgent Device Correction" letter dated February 23, 2009 was mailed by FedEx Tracking to all affected consignees. The letter described the issue, potential hazard and recommended precaution. Customers were instructed to complete the enclosed "Customer Response Fax Form" and return it via fax (1-732-667-1903) to Maquet, Inc. Maquet, Inc. will schedule repair service of the affected units once the "Customer Response Fax Form" is received. Direct questions to your local Maquet, Inc. Representative.

    Distribution

    Nationwide Distribution.

    Quantity

    54 of all units, both article numbers