BEUDAMED
    FDA Recall Terminated

    iBOT 3000 Mobility System. Independence IBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device. The device is shipped one each per wooden pallet with wooden sides and top retained by reusable bands.

    Recall: Z-1383-04 · Initiated July 1, 2004

    Recall

    Recall Number
    Z-1383-04
    Event Number
    29482
    Firm
    Independence Technology LLC
    FEI Number
    3003508375
    Product Code
    IMK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 1, 2004
    Posted
    August 24, 2004
    Terminated
    February 2, 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. The device is shipped one each per wooden pallet with wooden sides and top retained by reusable bands.

    Reason

    iBOT Mobility System may tip over due to malfunction in power base.

    Action

    Initial contact to consignees was by telephone on July 2,3,&4 2004. Letters were sent to all consignees from July 5,6,&8, 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 traning/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