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Revolution

by GE Healthcare Japan Corporation

Ref Revolution EVO

Revolution is a device classified as Class IIb in the EU and Class II in the US made by GE Healthcare Japan Corporation, registered in EUDAMED on 25 May 2026 (Basic UDI-DI B-00840682109796), cleared under FDA 510(k) K133640 on 25 Mar 2014 (1 earlier submission) and listed in FDA GUDID since 10 Jun 2016 (UDI-DI 00840682109796), active as of 23 Oct 2026. 8 FDA recalls are linked to it.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K133640

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00840682109796 Basic UDI-DI 00840682109796UDI-DIDate25 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682109796 UDI-DI Date10 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK133640 Date25 Mar 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00840682109796 registered 25 May 2026 Active
  • FDA 510(k) K133640 decided 25 Mar 2014 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00840682109796 listed 10 Jun 2016 Listed

Recalls

8 recalls · 2 ongoing · FDA

    • Ongoing Z-0608-2025 FDA Class II initiated 5 Nov 2024

    GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.

    • Ongoing Z-1900-2021 FDA Class II initiated 14 Jun 2021

    Improperly loaded software options may result in additional X -ray radiation exposure to the patient.

  • 2 recalls, same reason

    • Terminated Z-2583-2018 FDA Class II initiated 24 May 2018
    • Terminated Z-2584-2018 FDA Class II initiated 24 May 2018

    Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

  • 2 recalls, same reason

    • Terminated Z-2873-2018 FDA Class II initiated 27 Apr 2018
    • Terminated Z-2870-2018 FDA Class II initiated 27 Apr 2018

    GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.

  • 2 recalls, same reason

    • Terminated Z-2181-2017 FDA Class II initiated 19 May 2017
    • Terminated Z-2182-2017 FDA Class II initiated 19 May 2017

    It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Timeline

12 dated events

  1. Listed FDA GUDID 00840682109796
  2. Recall initiated FDA recalls Z-2181-2017
  3. Recall initiated FDA recalls Z-2182-2017
  4. Recall initiated FDA recalls Z-2873-2018
  5. Recall initiated FDA recalls Z-2870-2018
  6. Recall initiated FDA recalls Z-2583-2018
  7. Recall initiated FDA recalls Z-2584-2018
  8. Recall initiated FDA recalls Z-1900-2021
  9. Recall initiated FDA recalls Z-0608-2025
  10. Registered EUDAMED B-00840682109796

2 earlier events are in the sections above.

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
Revolution EVO EUDAMED
Revolution GUDID
Generic name
Full-body CT system
Model / reference
Revolution EVO EUDAMED
EVO GUDID
Primary DI / UDI-DI
00840682109796
Basic UDI-DI
B-00840682109796
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
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Revolution EVO
GUDID
EVO
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 (K131576)

Cleared under the same submission (K133640)

Similar devices in this category

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

Other devices from GE Healthcare Japan Corporation

See all devices from GE Healthcare Japan Corporation →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)