GE Healthcare CT Imaging System May Produce Rotated Medical Images
GE Healthcare CT systems may produce progressively rotated images during helical, cine, and cardiac scans. The issue affects 4 units worldwide and can cause rotations 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: This is a Class II FDA recall of a medical device with a documented functional defect affecting diagnostic imaging capability. Although no illnesses or injuries have been reported and anatomical positioning remains correct, rotated images present a real risk of diagnostic error or patient inconvenience through unnecessary rescans, qualifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
GE Healthcare has identified a potential issue with certain Discovery, Optima, and Revolution series CT imaging systems, including the Revolution Eagle Model Number 5849504-3, as well as certain operator console upgrades. The issue can result in rotated CT images, particularly during helical, cine, and cardiac scan modes. Four units have been identified and are distributed worldwide.
In affected scans, each image after the first can become progressively rotated. The amount of rotation depends on the gantry speed and scan duration, with maximum rotations reaching approximately 56 degrees. Although the entire anatomy rotates uniformly and anatomical positioning and z-axis orientation remain correct, the rotated images might not be immediately noticed. If image rotation is detected and a rescan is performed, the same rotation pattern will recur.
Healthcare facilities operating the affected equipment should obtain further information regarding this recall through GE Healthcare.
The recalled product
- Product
- GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Category
- Medical Device — CT System
- 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 (5)
- UDI/DI 00195278385215
- Serial/Sales Order Numbers: CBDPG2400006HM
- CBDPG2400005HM
- CBDPG2400004HM
- CBDPG2400007HM
Distribution
Distribution scope not specified by the agency.
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