BEUDAMED
    FDA Recall Terminated

    Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01. Product Usage: Human Non-AC-Powered Patient Lift

    Recall: Z-1431-2012 · Initiated April 6, 2012

    Recall

    Recall Number
    Z-1431-2012
    Event Number
    61547
    Firm
    KCI USA, Inc.
    FEI Number
    1625774
    Product Code
    FSA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 6, 2012
    Posted
    April 16, 2012
    Terminated
    June 19, 2012
    Address
    4958 Stout Dr, San Antonio, TX, 78219-4334

    Description

    Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01. Product Usage: Human Non-AC-Powered Patient Lift

    Reason

    The Zuma Mobility Assist and Trainer have the potential to bind during lowering operation.

    Action

    KCI sent an Urgent - Voluntary Medical Device Correction notification letters dated April 6, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. KCI will contact affected customers to schedule a time to upgrade the device. For questions contact KCL's Customer Technical Service Center at 1-800-275-4524. Select option 3 followed by option 2.

    Distribution

    USA Nationwide Distribution including the states of ID and FL

    Quantity

    4 units