BEUDAMED
    FDA Recall Terminated

    Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malvern, PA 19355. Intended for x-ray, angiographic use.

    Recall: Z-1732-2010 · Initiated April 12, 2010

    Recall

    Recall Number
    Z-1732-2010
    Event Number
    55647
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 12, 2010
    Posted
    May 28, 2010
    Terminated
    April 11, 2013
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malvern, PA 19355. Intended for x-ray, angiographic use.

    Reason

    sporadic malfunctions of the Artis Systems with Motor Controller caused by tolerances on electronic parts that might increase during the lifetime of the system.

    Action

    Siemens issued an "Urgent Field Safety Notice" to consignees describing the affected device instructing users to contact the recalling firm's service organization to schedule maintenance. For further information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-3237.

    Distribution

    Nationwide Distribution

    Quantity

    83 units