GE Healthcare Revolution Maxima CT Systems Recalled for Progressive Image Rotation
GE Healthcare recalled Revolution Maxima and related CT imaging systems that can produce progressively rotated images during helical, cine, and cardiac scans. Approximately 72 units worldwide are affected; no patient injuries reported.
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 device with a documented defect affecting diagnostic imaging quality. The progressive image rotation poses a risk of diagnostic interpretation error. No patient injuries or adverse events have been reported, which per the rubric limits the score to 3.
Plain-English summary
GE Healthcare has identified a potential defect in certain CT imaging systems that can cause progressive image rotation during helical, cine, and cardiac scans. Beginning after the first image in an exam, each subsequent image can be rotated by increasing amounts depending on gantry speed and scan duration, with maximum rotation reaching approximately 56 degrees.
Although the entire anatomy rotates uniformly without distortion and anatomical positioning and z-axis information remain correct, this image rotation could affect diagnostic interpretation. Small degrees of rotation may not be immediately noticed. If image rotation is detected and the examination must be repeated, the same rotation will occur in the rescanned images until the system is serviced.
Approximately 72 affected units have been distributed worldwide. Healthcare facilities using affected CT systems should contact GE Healthcare for service assessment and support.
The recalled product
- Product
- GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system
- 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 (20)
- 1) 6665000-2
- UDI/DI 00840682146180
- Serial/Sales Order Numbers: CBDMG2400130HM
- CBDMG2400134HM
- 2) 6670000-2
- Serial/Sales Order Numbers: CBDMG2400114HM
- CBDMG2400127HM
- CBDMG2400128HM
- CBDMG2400129HM
- CBDMG2400131HM
- CBDMG2400132HM
- CBDMG2400133HM
- CBDMG2400135HM
- CBDMG2400136HM
- CBDMG2400137HM
- CBDMG2400138HM
- CBDMG2400139HM
- CBDMG2400140HM
- CBDMG2400141HM
- CBDMG2400142HM
Distribution
Distribution scope not specified by the agency.
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