CT imaging system issue causes progressive image rotation during scans
GE Healthcare CT systems have a technical issue causing progressive image rotation during helical and cardiac scans. No injuries reported, but unnoticed rotation could affect diagnosis or require rescans.
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 recalls with no reported illnesses or injuries and documented risk of harm are scored 3 (High) per the rubric. This device has a functional defect that could lead to diagnostic error or unnecessary rescans, but no adverse events have been reported.
Plain-English summary
GE Healthcare is recalling four units of the Revolution Ascend Elite CT (computed tomography) imaging system, Model Number 6967000-100. The systems are distributed worldwide.
The systems can rotate images progressively during certain scan modes, particularly helical, cine, and cardiac scans. After the first image, each subsequent image can be rotated by an increasing amount. The final image can be rotated up to approximately 56 degrees. While the entire anatomy rotates as a complete unit without distortion and anatomical positioning remains correct, the image rotation can complicate diagnosis. Small degrees of rotation may not be immediately apparent, but if a patient requires a rescan due to noticed rotation, the same rotation will occur again.
No illnesses or injuries have been reported. GE Healthcare has classified this as a Class II recall. Healthcare facilities using the affected systems should contact GE Healthcare for guidance on corrective measures.
The recalled product
- Product
- GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Hazard
- image-rotation
- imaging-defect
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 (5)
- UDI/DI 00195278718129
- Serial/Sales Order Numbers: CBFLG2400002HM
- CBFLG2400005HM
- CBFLG2400004HM
- CBFLG2400003HM
Distribution
Distribution scope not specified by the agency.
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