GE Healthcare Revolution ACE CT Systems Image Rotation Issue
GE Healthcare's Revolution ACE CT systems can produce progressively rotated images during certain scan modes. Maximum rotation reaches 56 degrees, potentially affecting diagnostic interpretation.
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 FDA Class II recall involves a medical imaging system with a real defect (progressive image rotation) that could affect diagnostic accuracy. The hazard meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare has identified an issue affecting certain Revolution ACE CT imaging systems (Model 6670000-3). The systems can produce progressively rotated images during helical, cine, and cardiac scan modes.
After the first image in an examination, each subsequent image rotates by an increasing amount depending on gantry speed and scan duration. Maximum rotation can reach approximately 56 degrees. The entire anatomy rotates equally without distortion, and anatomical positioning and z-axis alignment remain correct. Small degrees of rotation may not be visually apparent.
Five Revolution ACE systems are affected (serial numbers CBDAG2400020HM, CBDAG2400021HM, CBDAG2400022HM, CBDAG2400023HM, CBDAG2400024HM). If image rotation is detected, rescans will exhibit the same rotated images. Healthcare facilities operating affected systems should contact GE Healthcare for further action.
The recalled product
- Product
- GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Hazard
- image-rotation
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 (6)
- UDI/DI 00840682146159
- Serial/Sales Order Numbers: CBDAG2400021HM
- CBDAG2400023HM
- CBDAG2400024HM
- CBDAG2400020HM
- CBDAG2400022HM
Distribution
Distribution scope not specified by the agency.
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