BEUDAMED
    FDA Recall Terminated

    SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system

    Recall: Z-0265-2020 · Initiated September 24, 2019

    Recall

    Recall Number
    Z-0265-2020
    Event Number
    83883
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 24, 2019
    Terminated
    July 8, 2024
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system

    Reason

    SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during interventional procedures

    Action

    Siemens issued a Customer Safety Advisory Notice to customers via CT072/19 on 9/24/2019. The letter identifies the problem, health risk and action to take: To avoid this issue, please refrain from using the i-Sequence scan mode in combination with the 3x3 mm collimation until this issue has been solved. Please use the i-Sequence with the 3x5 mm collimation instead, as here the correct dose information will be shown. This issue will be resolved with an improved software version syngo CT VA20A_SP2b. The software update will be released, free of charge, with the update CT073/19/S for all affected systems. The software update release is planned for Q3/2019. All future service packs will contain the update as well. Questions: contact service organization at 1-800-888-7436.

    Distribution

    US in the states of: GA, IN, MO, MS, NJ, OH, PA

    Quantity

    14 US