BEUDAMED
    FDA Recall Terminated

    Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. An accessory component for the MAGNUS operating table system. Used to mount head positioning accessories.

    Recall: Z-0480-2010 · Initiated October 22, 2009

    Recall

    Recall Number
    Z-0480-2010
    Event Number
    53612
    Firm
    Maquet Inc.
    FEI Number
    3008355164
    Product Code
    FWZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 22, 2009
    Posted
    December 2, 2009
    Terminated
    May 18, 2010
    Address
    45 Barbour Pond Drive, Wayne, NJ, 07470

    Description

    Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. An accessory component for the MAGNUS operating table system. Used to mount head positioning accessories.

    Reason

    Product monitoring has determined that the connection bracket shows potential mechanical play at the OR table interface for some procedures. This is due to the hole in the lock washer, which is responsible for locking the accessory to the OR table, being too large.

    Action

    Urgent Device Correction Letters were sent by Federal Express to affected US hospitals on October 22, 2009. The letter stated the technical description, potential hazard, and the recommended precaution. The letter asked customers to immediately verify whether their Connection Bracket is affected thru the FaxBack provided. Questions or need for additional information can be directed to customers' local MAQUET representative.

    Distribution

    Nationwide Distribution -- USA, including states of SC and PA.

    Quantity

    9 units in US.