BEUDAMED
    FDA Recall Terminated

    System AXIOM Aristos FX Plus - 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; and allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, and extremities. It is not designed for mammography use. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions.

    Recall: Z-1765-2020 · Initiated April 6, 2020

    Recall

    Recall Number
    Z-1765-2020
    Event Number
    85448
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    April 6, 2020
    Terminated
    October 27, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355

    Description

    System AXIOM Aristos FX Plus - 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; and allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, and extremities. It is not designed for mammography use. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions.

    Reason

    It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pressed. Exposure will be released for less than 500ms, therefore, the overall dose is estimated at 0.01mSv or less than 500 mGy in total.

    Action

    Only one user in the United States is affected by this corrective action. The Customer Safety Advisory Notice was sent to the affected customer. Any additional communication regarding this corrective action will include the following statement: The manufacturer will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included

    Distribution

    Worldwide Distribution

    Quantity

    399 (wordwide)