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SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac, SOMATOM Perspective SOMATOM Scope/ Scope Power

by Siemens Medical Solutions USA, Inc.

510(k) K142955

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

16 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK142955 Date24 Nov 2015ClearedStatusActive

Recalls

16 recalls · FDA

    • Terminated Z-0771-2021 FDA Class II initiated 24 Nov 2020

    System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan

    • Terminated Z-3025-2020 FDA Class II initiated 22 Jun 2020

    Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or patient rescan

    • Terminated Z-0406-2020 FDA Class II initiated 7 Oct 2019

    Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes

  • 9 recalls, same reason

    • Terminated Z-1446-2018 FDA Class II initiated 15 Feb 2018
    • Terminated Z-1445-2018 FDA Class II initiated 15 Feb 2018
    • Terminated Z-1449-2018 FDA Class II initiated 15 Feb 2018
    • Terminated Z-1455-2018 FDA Class II initiated 15 Feb 2018
    • Terminated Z-1450-2018 FDA Class II initiated 15 Feb 2018
    • Terminated Z-1456-2018 FDA Class II initiated 15 Feb 2018
    • Terminated Z-1458-2018 FDA Class II initiated 15 Feb 2018
    • Terminated Z-1457-2018 FDA Class II initiated 15 Feb 2018
    • Terminated Z-1447-2018 FDA Class II initiated 15 Feb 2018

    to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure

  • 4 recalls, same reason

    • Terminated Z-1745-2018 FDA Class II initiated 8 Nov 2017
    • Terminated Z-1747-2018 FDA Class II initiated 8 Nov 2017
    • Terminated Z-1746-2018 FDA Class II initiated 8 Nov 2017
    • Terminated Z-1748-2018 FDA Class II initiated 8 Nov 2017

    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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JAK
Device Class
Class II
Regulation
21 CFR Part 892.1750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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