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System SOMATOM Definition AS 08098027

by Siemens Healthcare GmbH

Part of a family of 20 devices: see the family page

Ref 08098027Model CT-Scanner_IIb_ERLN H 127

System SOMATOM Definition AS 08098027 is a device classified as Class IIb in the EU and Class II in the US made by Siemens Healthcare GmbH, registered in EUDAMED on 14 Apr 2026 (Basic UDI-DI 0405686900117UR), cleared under FDA 510(k) K230421 on 16 Jun 2023 (2 earlier submissions) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04056869003665), active as of 12 Nov 2026. 13 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K230421

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0405686900117UR Basic UDI-DI 04056869003665UDI-DIDate14 Apr 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK230421 Date16 Jun 2023DecidedStatusActive
United StatesGUDID listing GUDID Number04056869003665 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686900117UR registered 14 Apr 2026 Active
  • FDA 510(k) K230421 decided 16 Jun 2023 Active· +2 more in the status table
  • FDA GUDID UDI-DI 04056869003665 listed 24 Sep 2016 Listed

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.

Timeline

18 dated events

  1. Recall initiated FDA recalls Z-0285-2022
  2. Recall initiated FDA recalls Z-0283-2022
  3. Recall initiated FDA recalls Z-0286-2022
  4. Recall initiated FDA recalls Z-0289-2022
  5. Recall initiated FDA recalls Z-0475-2022
  6. Recall initiated FDA recalls Z-0473-2022
  7. Recall initiated FDA recalls Z-0472-2022
  8. Recall initiated FDA recalls Z-0474-2022
  9. Cleared FDA 510(k) K230421
  10. Registered EUDAMED 0405686900117UR

8 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
SOMATOM Definition AS EUDAMED
System SOMATOM Definition AS GUDID
Generic name
Full-body CT system
Device name
CT-Scanner_IIb_ERLN H 127
Model / reference
08098027, CT-Scanner_IIb_ERLN H 127
Primary DI / UDI-DI
04056869003665
Basic UDI-DI
0405686900117UR
510(k) Number
FDA product code
JAK
EMDN code
Z11030606 Computed tomographs - 128 layers or more but less than 256 layers
GMDN term
Full-body CT system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1750
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Full-body CT system

Cleared under the same submission (K190578)

and 2 more cleared under K190578

Cleared under the same submission (K230421)

and 2 more cleared under K230421

Similar devices in this category

Other devices filed under COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS.

Other devices from Siemens Healthcare GmbH

See all devices from Siemens Healthcare GmbH →

Properties

  • Serial number
Other properties (24, all answered No)