GE Healthcare Revolution Frontier CT systems may produce rotated images during scans
GE Healthcare Revolution Frontier CT systems can produce progressively rotated images during helical, cine, and cardiac scans. The rotation can reach up to 56 degrees and may require repeat scans.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device with no reported illnesses or injuries. The issue is a diagnostic imaging quality problem with theoretical risk of impacting diagnostic accuracy, but no cases of actual harm have been reported. This is a precautionary recall for a Class II device quality defect.
Plain-English summary
GE Healthcare has identified an issue affecting certain Revolution Frontier CT systems (models 5232085-213 and 5873009) that can produce progressively rotated images during helical, cine, and cardiac scan modes. After the first image, subsequent images rotate by increasing amounts, with maximum rotation around 56 degrees depending on gantry speed and scan duration. The images maintain correct anatomical positioning and z-axis orientation, but rotation may affect diagnostic accuracy.
Small degrees of rotation might not be noticed. If rotation requires a repeat scan, the same rotation will reoccur. This recall affects 3 units distributed worldwide. Facilities should contact GE Healthcare for a corrective action, such as a software update.
The recalled product
- Product
- GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system
- 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 (5)
- UDI/DI 00195278362230: 1) 5232085-213
- Serial/Sales Order Numbers: CBDUG2400017HM
- CBDUG2400016HM
- 2) 5873009
- Serial/Sales Order Numbers: CBDUG2400014HM
Distribution
Distribution scope not specified by the agency.
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