BEUDAMED
    FDA Recall Terminated

    iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device.

    Recall: Z-0022-05 · Initiated August 30, 2004

    Recall

    Recall Number
    Z-0022-05
    Event Number
    29703
    Firm
    Independence Technology LLC
    FEI Number
    3003508375
    Product Code
    IMK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 30, 2004
    Posted
    October 19, 2004
    Terminated
    April 1, 2005
    Address
    45 Technology Dr, Warren, NJ, 07059-5148

    Description

    iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device.

    Reason

    Rocks and debris can enter into the wheel cluster housing through a damaged wheel cap causing wheel malfunction.

    Action

    All individuals/organizations in possession of a device were notified by telephone beginning on August 30, 2004. Letters were mailed to all Customers on 8/31/2004 and to all Clinics on 9/1/2004.

    Distribution

    The Independence IBOT 3000 Mobility System was distributed to direct customers in the US, the UK, Ireland, and New Zealand. Ten of the US Direct customers received their devices via the VA. One training/demo/assessment device was distributed to the firm''s European support Centre (Ortho Clinical Diagnostics) in France. Two training/demo/assessment devices were distributed to a J&J representative in Japan.

    Quantity

    81 chairs