BEUDAMED
    FDA Recall Open, Classified

    Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.Now Model 11061610 NA* SOMATOM go.Now Model 11061618 NA* SOMATOM go.Up Model 11061620 SOMATOM go.Up Model 11061628 NA* SOMATOM go.All Model 11061630 SOMATOM go.All Model 11061638 NA* SOMATOM go.Top Model 11061640 SOMATOM go.Top Model 11061648 NA* SOMATOM X.cite Model 11330001 SOMATOME X.ceed Model 11330002 SOMATOM go.Sim Model 11061660 NA* SOMATOM go.Open Pro Model 11061670 NAEOTOM Alpha Model 11330003

    Recall: Z-1003-2023 · Initiated December 22, 2022

    Recall

    Recall Number
    Z-1003-2023
    Event Number
    91481
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 22, 2022
    Posted
    January 20, 2023
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.Now Model 11061610 NA* SOMATOM go.Now Model 11061618 NA* SOMATOM go.Up Model 11061620 SOMATOM go.Up Model 11061628 NA* SOMATOM go.All Model 11061630 SOMATOM go.All Model 11061638 NA* SOMATOM go.Top Model 11061640 SOMATOM go.Top Model 11061648 NA* SOMATOM X.cite Model 11330001 SOMATOME X.ceed Model 11330002 SOMATOM go.Sim Model 11061660 NA* SOMATOM go.Open Pro Model 11061670 NAEOTOM Alpha Model 11330003

    Reason

    In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped

    Action

    Siemens Customer Safety Advisory Notification CT083/22/S issued beginning on 12/23/2022 via email. Letter states reason for recall, health risk and action to take: When performing a CT intervention study, please make sure that the Recon parameter Image order is set to Head to Feet. Provides instruction on how to avoid the issue. Siemens is currently working on a permanent solution for this issue. This solution will be rolled out as a software update to all affected customers free of charge. Siemens is currently working on a permanent solution for this malfunction. This solution will be rolled out as a software update to your CT Scanner. The Siemens Service Organization will contact you as soon as the update is available. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understood the content therein. Regional Contact: Name: Rebecca Tudor Department: Post Market Regulatory Compliance Telephone: (484) 323-4198 Email: [email protected]

    Distribution

    Nationwide

    Quantity

    29 units U.S.