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.
What this means for you
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.
- Hazard
- image-rotation
- diagnostic-accuracy
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.
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