BEUDAMED
    FDA Recall Open, Classified

    ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.

    Recall: Z-1311-2023 · Initiated February 2, 2023

    Recall

    Recall Number
    Z-1311-2023
    Event Number
    91765
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    February 2, 2023
    Posted
    March 30, 2023
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.

    Reason

    In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.

    Action

    Siemens Healthcare issued A Customer Safety Advisory Notice distributed to customers on 2/2/23 via AX041/22/S. A software update to correct the error will be distributed to all affected customers via Update Instructions AX040/22/S. Affected systems will be updated to SW version VE10B. Letter states reason for recall, health risk and action to take: Please perform system movements with adequate care to avoid injuries to persons and damage to equipment due to collisions or crushing. Siemens will correct the software error via Update Instructions AX040/22/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content.

    Distribution

    US Nationwide distribution.

    Quantity

    141 units US