BEUDAMED
    FDA Enforcement Class II 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 · Reported July 31, 2013

    Enforcement

    Recall Number
    Z-1795-2013
    Event ID
    65604
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2013
    Initiation Date
    June 5, 2013
    Classification Date
    July 24, 2013
    Termination Date
    February 24, 2015
    Address
    51 Valley Stream Pkwy, N/A, Malvern, PA, 19355, United States

    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

    Code Info

    Model Number 5895003 with serial numbers 1052 through 2500.

    Distribution

    Nationwide Distribution.

    Quantity

    401