CT imaging systems may display progressively rotated images in certain scan modes
Certain GE Healthcare CT systems may display progressively rotated images, particularly during helical, cine, or cardiac scans. The rotation increases with each image, potentially reaching 56 degrees maximum.
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 risk-of-harm medical device with potential for diagnostic error due to progressive image rotation, but no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported score at most 3.
Plain-English summary
GE Healthcare has identified a malfunction in certain CT imaging systems (Revolution Advance model 5849504) where images displayed during scanning become progressively rotated. The issue primarily affects helical, cine, and cardiac scan modes. After the first image in an examination, each subsequent image rotates by an increasing amount.
The degree of rotation depends on gantry speed and scan duration, potentially reaching a maximum of approximately 56 degrees by the final image. The entire anatomy rotates uniformly without image distortion; anatomical positioning and the z-axis remain correct. Small degrees of rotation may not be immediately noticeable.
This recall affects 10 units distributed worldwide, identified by specific serial/sales order numbers (CBDLG2400031HM through CBDLG2400040HM). If rotated images are detected and a rescan becomes necessary, the same image rotation pattern will reoccur on the repeat scan.
Healthcare facilities operating the affected Revolution Advance model CT systems should contact GE Healthcare for guidance and instructions regarding system inspection or remediation.
The recalled product
- Product
- GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Affected units
- 10
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 (11)
- UDI/DI 00195278385215
- Serial/Sales Order Numbers: CBDLG2400031HM
- CBDLG2400035HM
- CBDLG2400034HM
- CBDLG2400038HM
- CBDLG2400036HM
- CBDLG2400033HM
- CBDLG2400037HM
- CBDLG2400032HM
- CBDLG2400039HM
- CBDLG2400040HM
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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