Agency classClass IIOur severity:High FDA (Devices)·Z-0601-2025·Announced 2024-12-11

GE Healthcare Optima 520 CT systems recalled for image rotation

GE Healthcare recalled 11 Optima 520 CT systems that produce progressively rotated scan images in helical, cine, and cardiac modes, potentially affecting diagnostic accuracy.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. The hazard—progressive image rotation affecting diagnostic imaging—represents a risk of harm but no adverse health consequences have been reported. Per the severity rubric, risk-of-harm products without reported injury score at most 3 (High).

Plain-English summary

GE Healthcare has identified a potential issue on certain Discovery, Optima, and Revolution series CT systems, as well as certain operator console upgrades. The GE Healthcare Optima 520 (catalog number 5439126, UDI/DI 00840682102568) with 11 units is affected and has been distributed worldwide.

The systems can produce progressively rotated CT images, particularly in helical, cine, and cardiac scan modes. After the first image of an exam, each subsequent image rotates by an increasing amount dependent on gantry speed and scan duration. The final image in an exam can be rotated up to approximately 56 degrees. The entire anatomy rotates uniformly as a whole without distortion, and anatomical positioning and z-axis of the images remain correct.

Small degrees of image rotation might not be noticed by operators. If image rotation is noticed and necessitates a rescan, the same image rotation will reoccur with the subsequent scan.

The recalled product

Product: GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
Manufacturer: GE Healthcare (China) Co., Ltd.
Category: Medical Device — Diagnostic Imaging
Hazard: image-rotation
diagnostic-accuracy
Affected units: 11

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

UDI/DI 00840682102568
Serial/Sales Order Numbers: CBDBG2400051HM
CBDBG2400048HM
CBDBG2400053HM
CBDBG2400049HM
CBDBG2400050HM
CBDBG2400052HM
CBDBG2400054HM
CBDBG2400055HM
CBDBG2400056HM
CBDBG2400057HM
CBDBG2400047HM

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 17 recalled by GE Healthcare (China) Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

Same manufacturer · GE Healthcare (China) Co., Ltd.

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Same hazard · image rotation