BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1746-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1746-2018
    Event ID
    79295
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 23, 2018
    Initiation Date
    November 8, 2017
    Classification Date
    May 15, 2018
    Termination Date
    May 18, 2023
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    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.

    Code Info

    Serial Numbers:83249 83277 83632 83336 83401 83204 83562 83564 83582 83390 83088 83234 83235 83645 83321 83527 83332 83026 83281 83558 83546 83339 83244 83585 83613 83226 83330 83214 83271 83607 83403 83599 83246 83388 83021 83584 83591 83574 83210 83552 83541 83020 83626 83308 83375 83227 83359 83031 83520 83262 83557 83081 83292 83090 83544 83083 83096 83294 83319 83581 83056 83041 83363 83307 83236 83348 83567 83378 83399 83258 83084 83004 83237 83205 83014 83573 83233 83352 83569 83537 83355 83395 83621 83335 83278 83322 83392 83622 83276 83279 83327 83091 83371 83533 83597 83034 83059 83230 83254 83267 83055 83291 83046 83524 83044 83243 83637 83640 83232 83362 83306 83542 83257 83539 83094 83239 83398 83565 83313 83653 83347 83349 83323 83324 83618 83266 83387 83516 83627 83095 83042 83611 83633 83589

    Distribution

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

    Quantity

    134