BEUDAMED
    FDA Recall Terminated

    Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.

    Recall: Z-1795-2013 · Initiated June 5, 2013

    Recall

    Recall Number
    Z-1795-2013
    Event Number
    65604
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 5, 2013
    Posted
    July 24, 2013
    Terminated
    February 24, 2015
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.

    Reason

    Siemens issued a Field Safety Notice about the potential hazard to patients or operators when using the function "table top float" of the AXIOM Aristos MX. When repositioning a patient lying on the table top and releasing the table top, it is possible that the fingers of the patient or operator are between the table top and the detector tray and if the table top is moved, the fingers can be squee

    Action

    On 6/5/13, consignees were notified by letter of a "Field Safety Notice" and received instructions about how to avoid the potential risk of this issue while using the device. Siemens also rolled out a modification of AXIOM Aristos MX that will avoid these potential injuries in the future.

    Distribution

    Nationwide Distribution.

    Quantity

    401