The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0616-2025·Announced 2024-12-11

GE Healthcare CT Scanner Console Images May Rotate After First Scan

Certain GE Healthcare CT scanner systems may produce progressively rotated images after the first scan, with rotation up to 56 degrees. While anatomical data remains intact, misaligned images could necessitate patient rescans.

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: This FDA Class II recall reports no illnesses or injuries. The hazard is diagnostic imaging accuracy impairment (progressive image rotation) that could necessitate patient rescans but does not directly cause physical harm. Anatomical data integrity is maintained.

Plain-English summary

GE Healthcare has identified a potential issue affecting certain Discovery, Optima, and Revolution series CT scanner systems, as well as certain operator console upgrades (FRU Spare Parts Number B80662DA). The affected equipment was distributed worldwide.

The issue involves image rotation in helical, cine, and cardiac scan modes. Beginning with the second image of an exam, subsequent images progressively rotate by increasing amounts. The degree of rotation depends on gantry speed and scan duration, with maximum rotation reaching approximately 56 degrees. The entire anatomy rotates uniformly without geometric distortion, and anatomical positioning and z-axis alignment remain correct.

Operators may not notice small degrees of image rotation. If rotation is detected and a patient rescan is performed, the same rotation pattern will occur on the rescanned images. GE Healthcare recommends that facilities using affected equipment contact them for further guidance and potential remediation options.

The recalled product

Product
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD
Manufacturer
GE Healthcare (China) Co., Ltd.
Category
Medical Device — Diagnostic Imaging / CT Scanner
Hazard
Affected units
1

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 (2)

  • UDI/DI N/A
  • Serial/Sales Order Numbers: 5472442

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 →

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