BEUDAMED
    FDA Recall Terminated

    Matrix MAX3 Actuator, Catalog Number: MAX30 A300545A2510V000, SKF USA, Inc. Norristown, PA 19403

    Recall: Z-0216-2008 · Initiated July 24, 2007

    Recall

    Recall Number
    Z-0216-2008
    Event Number
    44962
    Firm
    Skf USA Inc
    FEI Number
    3003668692
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    July 24, 2007
    Posted
    November 16, 2007
    Terminated
    April 26, 2013
    Address
    1111 Adams Ave, Norristown, PA, 19403-2403

    Description

    Matrix MAX3 Actuator, Catalog Number: MAX30 A300545A2510V000, SKF USA, Inc. Norristown, PA 19403

    Reason

    Sudden failure of the actuator during lifting operation

    Action

    On or about 7/24/07, the firm sent an Important Safety Information letter and instructions to all known OEMs who purchase and sell SKF actuators for use in patient lifts. The letter reiterated and emphasized the importance of proper handling and maintenance for the actuator. The firm enclosed with this correspondence a proposed letter that the OEMs were asked to send to their customers, including the safety instructions and a new warning label. The firm also is making available for OEMs, dealers and their customers new warning labels to place on all actuators in service. The root cause of the problem is still under investigation by the recalling firm and additional instruction may follow later

    Distribution

    Worldwide Distribution-USA and Canada

    Quantity

    1,298 units (Z-0215-0217-2008)