GE Healthcare Revolution Ascend CT System Recalled for Image Rotation
GE Healthcare Revolution Ascend CT systems can produce progressively rotated images during helical, cine, and cardiac scans. Images after the first may be rotated up to 56 degrees, potentially affecting diagnostic accuracy.
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 medical device recall affecting imaging accuracy with no reported illnesses or injuries. It represents a risk-of-harm product where diagnostic error could occur without documented patient impact, meeting the High severity category.
Plain-English summary
GE Healthcare is recalling 16 units of the Revolution Ascend CT system (Model 6969000-100) due to a defect causing progressive image rotation in certain scan modes.
When using helical, cine, or cardiac scan modes, images after the first image of an exam can become progressively rotated. The rotation increases with scan duration and gantry speed, with final images rotated up to approximately 56 degrees. While the entire anatomy rotates uniformly without distortion and anatomical positioning remains correct, the rotation can obscure the intended orientation. Small degrees of rotation might not be immediately noticed.
If image rotation is detected and a rescan is necessary, the same rotation will occur on the rescanned images. The affected units were distributed worldwide.
Healthcare facilities should contact GE Healthcare for guidance on identifying whether their system is affected and obtaining corrective measures or replacement equipment.
The recalled product
- Product
- GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Affected units
- 16
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 (17)
- UDI/DI 00840682146173
- Serial/Sales Order Numbers: CBDWG2400109HM
- CBDWG2400103HM
- CBDWG2400102HM
- CBDWG2400096HM
- CBDWG2400111HM
- CBDWG2400106HM
- CBDWG2400115HM
- CBDWG2400113HM
- CBDWG2400105HM
- CBDWG2400112HM
- CBDWG2400116HM
- CBDWG2400114HM
- CBDWG2400107HM
- CBDWG2400104HM
- CBDWG2400110HM
- CBDWG2400108HM
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 17 recalled by GE Healthcare (China) Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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