Revolution AceRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682146159), 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).

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

4 other recalls cover devices cleared under the same FDA submission (K192686); 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. Nov 5, 2024Open, 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 · FDA record ↗

2. Jun 2, 2022Open, 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 · 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.

• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192686. One submission often covers many models, so check the product and lot details in each record.

• Z-0612-2025 · Nov 5, 2024 · Open, Classified
  GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
• Z-0606-2025 · Nov 5, 2024 · Open, Classified
  GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
• Z-0610-2025 · Nov 5, 2024 · Open, Classified
  GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system
• Z-0611-2025 · Nov 5, 2024 · Open, Classified
  GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system