GE Healthcare CT System May Produce Rotated Diagnostic Images
GE Healthcare's Revolution Maxima M and related CT systems may produce progressively rotated images during scans, potentially compromising diagnostic accuracy. Rotation increases with each image, reaching up to 56 degrees.
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 recall with no reported illnesses or injuries. The hazard involves real image rotation that could compromise diagnostic accuracy, fitting the rubric criterion of a risk-of-harm product where injury has not yet been reported.
Plain-English summary
GE Healthcare has issued a recall for certain Discovery, Optima, and Revolution series CT systems, as well as related operator console upgrades. The affected equipment can produce CT images that become progressively rotated during helical, cine, and cardiac scans. After the first image of an examination, each subsequent image rotates by an increasing amount.
The degree of rotation depends on the gantry speed and scan duration. Images in a single exam can be rotated up to approximately 56 degrees by the end of the scan. While the anatomy itself rotates as a single unit without distortion, and the z-axis positioning remains correct, the rotation may compromise diagnostic accuracy. Small rotations may go unnoticed by clinicians.
If rotated images are detected and a patient rescan is necessary, the same image rotation pattern will reoccur. Facilities operating affected systems should contact GE Healthcare for guidance. The recall affects 3 units with serial numbers CBDOG2400029HM, CBDOG2400031HM, and CBDOG2400030HM, distributed worldwide.
The recalled product
- Product
- GE Healthcare Revolution Maxima M, Model Number, 6670000-2; 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 (4)
- UDI/DI 0019527856860
- Serial/Sales Order Numbers: CBDOG2400029HM
- CBDOG2400031HM
- CBDOG2400030HM
Distribution
Distribution scope not specified by the agency.
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