Agency classClass IIOur severity:High FDA (Devices)·Z-0610-2025·Announced 2024-12-11

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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.
Category: Medical Device — Diagnostic Imaging / CT Scanner
Hazard: image-rotation
Affected units: 72

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.

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.

See all 17 products in this recall →

Same manufacturer · GE Healthcare (China) Co., Ltd.

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Same hazard · image rotation