BEUDAMED
    FDA Recall Terminated

    SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system

    Recall: Z-1746-2018 · Initiated November 8, 2017

    Recall

    Recall Number
    Z-1746-2018
    Event Number
    79295
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 8, 2017
    Terminated
    May 18, 2023
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system

    Reason

    There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.

    Action

    Siemens Medical Solutions USA, Inc. will bring defect into Compliance noted below: 1.You will contact customers and initiate the actions to correct the failure to comply issue. 2. You will provide a software update to correct tube current calculations by the CARE Dose4D algorithm for head scans. 3.You will follow-up with consignees to verify the effectiveness of the software update. CDRH approves the CAP subject to the following conditions: 1.Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) division office coordinator noted below are to be included. For further questions, please call (610) 448-6471.

    Distribution

    Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.

    Quantity

    134