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FDAFDA · Food and drugs·Recall number Z-0609-2025

GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system

Published December 11, 2024 · Recall initiated: November 5, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
GE Healthcare (China) Co., Ltd.
Distributor
Worldwide distribution.
Lot
UDI/DI 00195278362230: 1) 5232085-213, Serial/Sales Order Numbers: CBDUG2400017HM, CBDUG2400016HM; 2) 5873009, Serial/Sales Order Numbers: CBDUG2400014HM
Risk classification
Class II
Area (FDA)
device
Country
China

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