Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0609-2025·Announced 2024-12-11

GE Healthcare Revolution Frontier CT systems may produce rotated images during scans

GE Healthcare Revolution Frontier CT systems can produce progressively rotated images during helical, cine, and cardiac scans. The rotation can reach up to 56 degrees and may require repeat scans.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II device with no reported illnesses or injuries. The issue is a diagnostic imaging quality problem with theoretical risk of impacting diagnostic accuracy, but no cases of actual harm have been reported. This is a precautionary recall for a Class II device quality defect.

Plain-English summary

GE Healthcare has identified an issue affecting certain Revolution Frontier CT systems (models 5232085-213 and 5873009) that can produce progressively rotated images during helical, cine, and cardiac scan modes. After the first image, subsequent images rotate by increasing amounts, with maximum rotation around 56 degrees depending on gantry speed and scan duration. The images maintain correct anatomical positioning and z-axis orientation, but rotation may affect diagnostic accuracy.

Small degrees of rotation might not be noticed. If rotation requires a repeat scan, the same rotation will reoccur. This recall affects 3 units distributed worldwide. Facilities should contact GE Healthcare for a corrective action, such as a software update.

The recalled product

Product: GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system
Manufacturer: GE Healthcare (China) Co., Ltd.
Category: Medical Device — Diagnostic Imaging / CT Systems
Hazard: image-rotation
diagnostic-accuracy
Affected units: 3

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 00195278362230: 1) 5232085-213
Serial/Sales Order Numbers: CBDUG2400017HM
CBDUG2400016HM
2) 5873009
Serial/Sales Order Numbers: CBDUG2400014HM

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