BEUDAMED
    FDA Recall Open, Classified

    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

    Recall: Z-0962-2022 · Initiated March 7, 2022

    Recall

    Recall Number
    Z-0962-2022
    Event Number
    89901
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    March 7, 2022
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

    Reason

    Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Results in potential patient issues: Possible rescan , Unexpected X-Ray dose and additional contrast media, Delay in diagnosis, scan abort,and patient rescan

    Action

    Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to customers via CT010/22/S via email/mail on March 7, 2022. Letter states reason for recall, health risk and action to take: There are no workarounds for these issues. Customers are urged to install the remote update as soon as it is released. How will the corrective action be implemented and what is the efficiency of the corrective actions? Siemens has developed software update syngo CT VA30A_SP5 to ensure more stable scanning workflows, reduce the number of user notifications, and to further improve the image quality and reduce image artifacts. This update will provide workflow improvements, bug fixes for performance and stability problems observed in installed base. Corrective action will be provided free of charge and will be remotely distributed via Update Instruction CT008/22/S or CT088/21/S (X.cite only). The remote software update process will require approximately 180 minutes for completion. If you have any technical or scheduling questions, please contact our service organization 1-800-888-7436. You may also reach to the Regional Unit Contact listed on the first page of this notification. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. Acknowledge Receipt of this Safety Advisory Notice 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 understood the content therein. Please include your Siemens system names, material numbers, serial numbers, and Siemens Functional Location numbers and email this information to: [email protected]. Additionally, a software solution (VA30A_SP5) to eliminate the root cause of this problem is being distributed via CT008/22/S or CT088/21/S (X.cite only) to all affected customers free of charge. Fol

    Distribution

    Nationwide

    Quantity

    547 units US