BEUDAMED
    FDA Recall Terminated

    AlterG Anti-Gravity Treadmill; Alter G, 48349 Milmont Drive, Fremont, Ca 94538 Product Usage: Rehabilitation of lower body injury & Neurological conditions.

    Recall: Z-3026-2011 · Initiated July 15, 2011

    Recall

    Recall Number
    Z-3026-2011
    Event Number
    59408
    Firm
    Alter-G, Incorporated
    FEI Number
    3008089345
    Product Code
    BXB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 15, 2011
    Posted
    August 16, 2011
    Terminated
    August 16, 2011
    Address
    48438 Milmont Dr, Fremont, CA, 94538-7326

    Description

    AlterG Anti-Gravity Treadmill; Alter G, 48349 Milmont Drive, Fremont, Ca 94538 Product Usage: Rehabilitation of lower body injury & Neurological conditions.

    Reason

    Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting.

    Action

    Alter-G, Inc. notified all affected customers by telephone, e-mail and followed by a "Medical Device Customer Advisory Notification" letter dated July 15, 2011. Customers were provided information on the installation error, the potential harm to patients, and the actions to be taken. The letter instructs customers to discontinue use of the Alter G until the recalling firm can evaluate the machine and correct any installation error. The letter states that the recalling firm is planning to visit affected customer's facility as quickly as possible and will contact customers to schedule this visit. Questions or concerns should be directed to David Tjon at 510-270-5369.

    Distribution

    Nationwide Distribution (USA ) - including the states of: OK and TX.

    Quantity

    16 potentially affected units