Reported Dec 11, 2024 · Ongoing
GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
GE Healthcare (China) Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare (China) Co., Ltd. · 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area · Beijing · N/A
Is this the product you have?
GE Healthcare Optima 520Catalog number 5439126X-ray/computed tomography systems
- Lot codes and dates
- UDI/DI 00840682102568
- Serial/Sales Order Numbers
CBDBG2400051HMCBDBG2400048HMCBDBG2400053HMCBDBG2400049HMCBDBG2400050HMCBDBG2400052HMCBDBG2400054HMCBDBG2400055HMCBDBG2400056HMCBDBG2400057HMCBDBG2400047HM
- Amount recalled
- 11 units
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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