RevolutionRecalls & reported problems across all models

We found 10 models of Revolution by GE Hangwei Medical Systems Company Ltd. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Nov 8, 2024 and Nov 8, 2024 — classified as 1 injury.

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

8 FDA recall records name at least one of these models by its device identifier, 8 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Revolution recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 26, 2026Class IIOpen, 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-2155-2026 · Root cause: Software design · Recall details · FDA record ↗

2. Feb 18, 2025Class IIOpen, 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-1297-2025 · Root cause: Process change control · Recall details · FDA record ↗

3. Nov 5, 2024Class IIOpen, Classified

   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.

   Z-0610-2025 · Root cause: Component design/selection · names 2 of these models · Recall details · FDA record ↗

4. Nov 5, 2024Class IIOpen, Classified

   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.

   Z-0609-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

5. Nov 5, 2024Class IIOpen, Classified

   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.

   Z-0607-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

6. Nov 5, 2024Class IIOpen, Classified

   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.

   Z-0604-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

7. Nov 5, 2024Class IIOpen, Classified

   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.

   Z-0603-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

8. Jun 2, 2022Class IIOpen, Classified

   As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel.

   Z-1511-2022 · Root cause: Error in labeling · names 7 of these models · Recall details · FDA record ↗

Most reported Revolution problems

Revolution models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Revolution Advance

  System, x-ray, tomography, computed
  3 recalls0 reports
• Revolution Ace

  System, x-ray, tomography, computed
  2 recalls1 report
• Revolution Apex Select

  System, x-ray, tomography, computed
  2 recalls0 reports
• Revolution Maxima

  System, x-ray, tomography, computed
  2 recalls0 reports
• Revolution Frontier MDR

  System, x-ray, tomography, computed
  1 recall0 reports
• Revolution Eagle

  System, x-ray, tomography, computed
  1 recall0 reports
• Revolution Maxima H

  System, x-ray, tomography, computed
  1 recall0 reports
• Revolution ACT

  System, x-ray, tomography, computed
  1 recall0 reports
• Revolution Frontier

  System, x-ray, tomography, computed
  1 recall0 reports
• Revolution Maxima US

  System, x-ray, tomography, computed
  1 recall0 reports

Recent Revolution adverse event reports

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

• InjuryNov 8, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A PATIENT SUSTAINED AN ELBOW FRACTURE WHEN THEIR ARM (WHICH WAS NOT SECURED WITH PATIENT STRAPS) MOVED OFF THE TABLE AND STRUCK THE GANTRY WHILE THE TABLE WAS MOVING INTO THE BORE. THERE IS NO INDICATION OF DEVICE MALFUNCTION.

  Patient problems: Limb Fracture

  MAUDE report 20641460 ↗

Other GE Hangwei Medical Systems Company Ltd. products

• Optima5 models · 0 reports · 3 recalls