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Revolution Ace

by GE Hangwei Medical Systems Company Ltd.

Revolution Ace (RevolutionAce) is a Class II device made by GE Hangwei Medical Systems Company Ltd., cleared under FDA 510(k) K192686 on 24 Oct 2019 and listed in FDA GUDID since 4 Nov 2019 (UDI-DI 00840682146159), active as of 23 Oct 2026. 5 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 ongoing

This device is named in the recall

Documents

510(k) K192686

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682146159 UDI-DI Date4 Nov 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK192686 Date24 Oct 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192686 decided 24 Oct 2019 Active
  • FDA GUDID UDI-DI 00840682146159 listed 4 Nov 2019 Listed

Recalls

5 recalls · 5 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-0612-2025 FDA Class II initiated 5 Nov 2024
    • Ongoing Z-0603-2025 FDA Class II initiated 5 Nov 2024
    • Ongoing Z-0610-2025 FDA Class II initiated 5 Nov 2024
    • Ongoing Z-0606-2025 FDA Class II initiated 5 Nov 2024
    • Ongoing Z-0611-2025 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.

Timeline

7 dated events

  1. Cleared FDA 510(k) K192686
  2. Listed FDA GUDID 00840682146159
  3. Recall initiated FDA recalls Z-0612-2025
  4. Recall initiated FDA recalls Z-0603-2025
  5. Recall initiated FDA recalls Z-0610-2025
  6. Recall initiated FDA recalls Z-0606-2025
  7. Recall initiated FDA recalls Z-0611-2025

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Revolution
Generic name
Full-body CT system
Model / Ref / Catalog
Ace, RevolutionAce
Primary DI / UDI-DI
00840682146159
510(k) Number
FDA product code
JAK
GMDN term
Full-body CT system
Device class
Class II
Regulation number
892.1750
GUDID distribution status
In Commercial Distribution

Related devices

Category: Full-body CT system

Cleared under the same submission (K192686)

and 1 more cleared under K192686

Similar devices in this category

Other devices filed under Full-body CT system.

Other devices from GE Hangwei Medical Systems Company Ltd.

  • Operator Console

    Class II

  • Optima CT680 Expert Open recall

    Class II

  • Revolution Ascend Sliding

    Class II

  • Optima Advance Open recall

    Class II

See all devices from GE Hangwei Medical Systems Company Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)