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SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence

by Siemens Medical Solutions USA, Inc.

510(k) K190578

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK190578 Date27 Jun 2019ClearedStatusActive

Recalls

13 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-0475-2022 FDA Class II initiated 19 Nov 2021
    • Ongoing Z-0473-2022 FDA Class II initiated 19 Nov 2021
    • Ongoing Z-0472-2022 FDA Class II initiated 19 Nov 2021
    • Ongoing Z-0474-2022 FDA Class II initiated 19 Nov 2021

    Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.

  • 7 recalls, same reason

    • Terminated Z-0287-2022 FDA Class II initiated 30 Aug 2021
    • Terminated Z-0288-2022 FDA Class II initiated 30 Aug 2021
    • Terminated Z-0284-2022 FDA Class II initiated 30 Aug 2021
    • Terminated Z-0285-2022 FDA Class II initiated 30 Aug 2021
    • Terminated Z-0283-2022 FDA Class II initiated 30 Aug 2021
    • Terminated Z-0286-2022 FDA Class II initiated 30 Aug 2021
    • Terminated Z-0289-2022 FDA Class II initiated 30 Aug 2021

    software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

    • Terminated Z-2440-2019 FDA Class II initiated 25 Jul 2019

    SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans

    • Terminated Z-2270-2019 FDA Class II initiated 3 Jul 2019

    Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

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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