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Revolution Apex

by GE Medical Systems, LLC United States EUDAMEDGUDID

Ref Revolution ApexModel Revolution

Product code JAKEMDN Z11030607

Regulatory status

as of 25 Oct 2026

Recall ongoing. 12 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00014GP Basic UDI-DIDate7 Mar 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682146616 UDI-DIDate27 Nov 2019ListedStatusIn distribution

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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

18 recalls · 12 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-2154-2026 FDA Class II initiated 26 Mar 2026
    • Ongoing Z-2152-2026 FDA Class II initiated 26 Mar 2026
    • Ongoing Z-2153-2026 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.

  • 3 recalls, same reason

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

    • Ongoing Z-0242-2022 FDA Class II initiated 30 Jun 2021

    The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.

  • 2 recalls, same reason

    • Ongoing Z-0815-2022 FDA Class II initiated 30 Jun 2021
    • Ongoing Z-0816-2022 FDA Class II initiated 30 Jun 2021

    The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.

  • 2 recalls, same reason

    • Ongoing Z-2021-2021 FDA Class II initiated 30 Jun 2021
    • Ongoing Z-2022-2021 FDA Class II initiated 30 Jun 2021

    When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.

    • Completed Z-2004-2021 FDA Class II initiated 19 Mar 2021

    GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.

  • 2 recalls, same reason

    • Terminated Z-1129-2021 FDA Class II initiated 17 Dec 2020
    • Terminated Z-1130-2021 FDA Class II initiated 17 Dec 2020

    GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.

  • 2 recalls, same reason

    • Terminated Z-0694-2021 FDA Class II initiated 23 Nov 2020
    • Terminated Z-0695-2021 FDA Class II initiated 23 Nov 2020

    A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling

    • Terminated Z-0306-2021 FDA Class II initiated 21 Sep 2020

    There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Revolution Apex EUDAMED
Revolution GUDID
Generic Name
Full-body CT system
Model / Ref / Catalog
Revolution EUDAMED
Revolution Apex EUDAMED
Apex GUDID
5590000-20 GUDID
Primary DI / UDI-DI
00840682146616
Basic UDI-DI
8406821BUG00014GP
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
Revolution Apex
GUDID
Apex
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000018315
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Other devices from Ge Medical Systems, Inc.

See all devices from Ge Medical Systems, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Serial Number
Other properties (22)
  • 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
  • Prescription Use: 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 ba6f91dc-7d13-448b-b7ad-af8fac371014 61 fields · synced 22 Oct 2026
  • FDA UDI 7e267c64-bcc4-4be0-8635-f80937718d9f 35 fields · synced 30 May 2026