GE Healthcare (China) Co., Ltd.: Medical Device Recall in 2024 - (Recall #: Z-0608-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system

Product Classification:

Class II

Date Initiated: November 5, 2024

Date Posted: December 11, 2024

Recall Number: Z-0608-2025

Event ID: 95704

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.

Status: Ongoing

Product Quantity: 2 units

Code Information:

UDI/DI 00840682109796, Serial/Sales Order Numbers: CBDGG2400018HM, CBDGG2400017HM

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated