BEUDAMED
    FDA Recall Terminated

    Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1

    Recall: Z-0389-2012 · Initiated September 19, 2011

    Recall

    Recall Number
    Z-0389-2012
    Event Number
    60344
    Firm
    Maquet Inc.
    FEI Number
    3008355164
    Product Code
    LFQO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 19, 2011
    Posted
    January 11, 2012
    Terminated
    December 8, 2011
    Address
    45 Barbour Pond Drive, Wayne, NJ, 07470

    Description

    Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1

    Reason

    A component of the Magnus hybrid OR system fails to respond to a position command.

    Action

    Maquet sent a PRODUCT RECALL URGENT MEDICAL DEVICE CORRECTIVE ACTION letter dated September 19, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. To avoid the potential of a malfunction occurring prior to their scheduled Service procedure, customers were instructed to ensure that the MAGNUS table-top is positioned at the "0" pivot position and that the MAGNUS column pivot brake is secured. If it is necessary to pivot the MAGNUS table-top prior to procedure start, ensure that the column pivot brake is completely released and then completely secured when returned to "0" pivot position. Customers were instructed to ensure that all user of the affected product and other necessary persons are informed of the product correction notice. For technical support or questions call 1-888-627-8383

    Distribution

    Worldwide Distribution - USA including VA, LA, MO, NC, MD, and AZ and the countries of AE, AU, CA, CH, CN, DE, DK, ES, IE, IL, SP, PL, RU, and TH.

    Quantity

    45 UNITS