PlainRecalls
FDA Devices Moderate Class II Ongoing

GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems

Reported: December 11, 2024 Initiated: November 5, 2024 #Z-0603-2025

Product Description

GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems

Reason for Recall

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.

Details

Units Affected
5 units
Distribution
Worldwide distribution.
Location
Beijing

Frequently Asked Questions

What product was recalled?
GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems. Recalled by GE Healthcare (China) Co., Ltd.. Units affected: 5 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 11, 2024. Severity: Moderate. Recall number: Z-0603-2025.