BEUDAMED
    FDA Recall Terminated

    AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device.

    Recall: Z-1583-2015 · Initiated April 14, 2015

    Recall

    Recall Number
    Z-1583-2015
    Event Number
    71029
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 14, 2015
    Posted
    May 5, 2015
    Terminated
    August 17, 2016
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device.

    Reason

    If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators.

    Action

    The firm, Siemens Healthcare, sent a "Safety Advisory Notice" dated April 14, 2015, to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to follow the instructions in the notice; promptly notify and instruct all the staff at your organization making them aware of the problem; and forward this safety information to other organizations that could be affected. If the device has been sold and therefore no longer in your possession, forward the safety notice to the new owner. Additionally, customers were instructed observe this safety notice and comply with the corresponding measures until the update has been fully completed. If you have any questions, contact customer support at 610-219-6300.

    Distribution

    Nationwide Distribution.

    Quantity

    43