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SOMATOM Definition Flash (VA48)

by Siemens Medical Solutions USA, Inc.

510(k) K143416

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

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 NumberK143416 Date16 Apr 2015ClearedStatusActive

Recalls

5 recalls · FDA

    • Terminated Z-0743-2017 FDA Class II initiated 15 Nov 2016

    Software update that provides software and firmware bug-fixes to improve system performance

    • Terminated Z-0608-2017 FDA Class II initiated 2 Nov 2016

    Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.

    • Terminated Z-0374-2017 FDA Class II initiated 19 Oct 2016

    Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts.

    • Terminated Z-2625-2016 FDA Class II initiated 13 Jul 2016

    Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.

    • Terminated Z-0020-2016 FDA Class II initiated 14 Aug 2015

    software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin

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  • Withdrawn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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