Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0606-2025 — GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system

U.S. FDA — Device Enforcement · China · 2024-11-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0606-2025
Date of alert
2024-11-05
Country / jurisdiction
China
Risk level
Class II
Risk type
recall
Brand
GE Healthcare (China) Co., Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00195278718129
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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