BEUDAMED
    FDA Recall Terminated

    iBOT 4000 Mobility System Battery pack.

    Recall: Z-1775-2010 · Initiated February 22, 2010

    Recall

    Recall Number
    Z-1775-2010
    Event Number
    54643
    Firm
    Independence Technology LLC
    FEI Number
    3003508375
    Product Code
    IMK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 22, 2010
    Posted
    June 5, 2010
    Terminated
    October 1, 2010
    Address
    45 Technology Dr, Warren, NJ, 07059-5148

    Description

    iBOT 4000 Mobility System Battery pack.

    Reason

    A thermal breaker in the battery pack has the potential to open due to overheating and disable one third of the cells in the affected battery pack.

    Action

    The company sent Medical Device Field Correction letters to all customers on February 22, 2010 by certified mail.

    Distribution

    Nationwide and to the United Kingdom.

    Quantity

    192 devices