GE Healthcare CT Systems Recalled Due to Progressive Image Rotation
GE Healthcare CT systems may display progressively rotated images, particularly in helical, cine, and cardiac scans. Rotations up to 56 degrees may affect image interpretation and could necessitate additional patient scanning.
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: This is a FDA Class II medical device recall without reported patient injuries or illnesses. The confirmed image rotation defect that could affect diagnostic accuracy or necessitate additional patient scanning represents risk of harm without yet causing harm, matching the 'risk-of-harm products where injury has not yet been reported' criterion for Score 3.
Plain-English summary
GE Healthcare is recalling certain CT systems from the Discovery, Optima, and Revolution series, including Model 5454001-260, due to a potential issue that causes progressive rotation of diagnostic images. The recall involves 2 systems with worldwide distribution.
The systems may display progressively rotated images, particularly when using helical, cine, and cardiac scan modes. After the first image of an exam, each subsequent image can be rotated by an increasing amount, with the final image potentially rotated up to approximately 56 degrees. The entire anatomy rotates as a unit without distortion, and anatomical positioning and z-axis orientation remain correct.
Small degrees of image rotation may not be immediately noticed. If image rotation is detected and necessitates a rescan of the patient, the same rotation pattern will recur in the rescanned images.
The recalled product
- Product
- GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Hazard
- image-rotation
- diagnostic-error
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 (3)
- UDI/DI 00840682109796
- Serial/Sales Order Numbers: CBDGG2400018HM
- CBDGG2400017HM
Distribution
Distribution scope not specified by the agency.
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