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Revolution Apex Select with Plus Edition

by Ge Hangwei Medical Systems Co., Ltd. China EUDAMEDGUDID

Ref Revolution Apex Select with Plus Edition Product code JAKEMDN Z11030607

Regulatory status

as of 26 Oct 2026

Recall ongoing. 11 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00195278788665 UDI-DIDate26 Dec 2023ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number8406821BUG00213GX Basic UDI-DIDate14 Mar 2022RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

11 recalls · 11 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-2153-2026 FDA Class II initiated 26 Mar 2026
    • Ongoing Z-2155-2026 FDA Class II initiated 26 Mar 2026
    • Ongoing Z-2151-2026 FDA Class II initiated 26 Mar 2026
    • Ongoing Z-2154-2026 FDA Class II initiated 26 Mar 2026
    • Ongoing Z-2152-2026 FDA Class II initiated 26 Mar 2026
    • Ongoing Z-2150-2026 FDA Class II initiated 26 Mar 2026

    GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

  • 5 recalls, same reason

    • Ongoing Z-1300-2025 FDA Class II initiated 18 Feb 2025
    • Ongoing Z-1303-2025 FDA Class II initiated 18 Feb 2025
    • Ongoing Z-1298-2025 FDA Class II initiated 18 Feb 2025
    • Ongoing Z-1301-2025 FDA Class II initiated 18 Feb 2025
    • Ongoing Z-1297-2025 FDA Class II initiated 18 Feb 2025

    GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Revolution Apex Select with Plus Edition EUDAMED
Revolution Apex GUDID
Generic Name
Full-body CT system
Model / Ref / Catalog
Revolution Apex Select with Plus Edition EUDAMED
Select with Plus Edition GUDID
B7919YO GUDID
Primary DI / UDI-DI
00195278788665
Basic UDI-DI
8406821BUG00213GX
510(k) Number
FDA Product Code
JAK
EMDN Code
Z11030607 Computed tomographs - 256 layers or more
GMDN Term
Full-body CT system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.1750
Market of Registration
Denmark
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Revolution Apex Select with Plus Edition
GUDID
Select with Plus Edition
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000009292
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Other devices from Ge Hangwei Medical Systems Co., Ltd.

See all devices from Ge Hangwei Medical Systems Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Prescription Use
  • Serial Number
Other properties (21)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED 0b532625-02db-46dd-a437-606219340b44 61 fields · synced 22 Oct 2026
  • FDA UDI 87b44488-3474-4839-bdcb-b31d62c9a030 35 fields · synced 30 May 2026