Revolution Apex PlusRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00195278502179), received between Jan 13, 2026 and Jan 13, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

17 other recalls cover devices cleared under the same FDA submission (K191777); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 26, 2026Open, Classified

   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.

   Z-2152-2026 · Root cause: Software design · FDA record ↗

2. Feb 18, 2025Open, Classified

   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.

   Z-1302-2025 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, DURING INSTALLATION OF THE SYSTEM, A FIELD ENGINEER'S THUMB GOT PINCHED IN THE TABLE SPRING, CAUSING A WOUND THAT WAS TREATED WITH SURGERY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24054776 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191777. One submission often covers many models, so check the product and lot details in each record.

• Z-2150-2026 · Mar 26, 2026 · Open, Classified
  Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
• Z-2153-2026 · Mar 26, 2026 · Open, Classified
  Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
• Z-2154-2026 · Mar 26, 2026 · Open, Classified
  Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
• Z-1300-2025 · Feb 18, 2025 · Open, Classified
  GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed
• Z-1303-2025 · Feb 18, 2025 · Open, Classified
  GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
• Z-1297-2025 · Feb 18, 2025 · Open, Classified
  GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
• Z-0816-2022 · Jun 30, 2021 · Open, Classified
  Revolution CT, Revolution CT ES
• Z-2021-2021 · Jun 30, 2021 · Open, Classified
  The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different a
• Z-0815-2022 · Jun 30, 2021 · Open, Classified
  Revolution Apex, Revolution CT with Apex Edition
• Z-2022-2021 · Jun 30, 2021 · Open, Classified
  The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different a
• Z-0242-2022 · Jun 30, 2021 · Open, Classified
  Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
• Z-2004-2021 · Mar 19, 2021 · Completed
  Revolution CT
• Z-1130-2021 · Dec 17, 2020 · Terminated
  System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
• Z-1129-2021 · Dec 17, 2020 · Terminated
  System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
• Z-0695-2021 · Nov 23, 2020 · Terminated
  Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

…and 2 more.