BEUDAMED
    FDA Recall Terminated

    e-fix E20 power drive. The product is a wheelchair component/accessory.

    Recall: Z-0804-05 · Initiated August 1, 2004

    Recall

    Recall Number
    Z-0804-05
    Event Number
    31773
    Firm
    Frank Mobility Systems, Inc.
    FEI Number
    1000522778
    Product Code
    ITI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 1, 2004
    Posted
    May 6, 2005
    Terminated
    August 23, 2006
    Address
    1003 International Dr, Oakdale, PA, 15071-9226

    Description

    e-fix E20 power drive. The product is a wheelchair component/accessory.

    Reason

    may short circuit within the interface due to long term exposure of liquid

    Action

    The recalling firm issued a Corrective Action Notice to their customers on 9/1/04 via certified mail return receipt. The notice described the problem and the correction (interface was designed). The notice also instructed the dealers/distributors to notify their customers and have the units brought back to them for the exchange.

    Distribution

    The products were shipped to distributors nationwide. The product was also shipped to Mexico and Panama.

    Quantity

    314 units