The Recall Desk
ModerateFDA (Devices)·Z-2021-2021·Announced 2021-07-14

GE Revolution CT User Interface Issue with Scan Groups

The GE Revolution CT user interface may fail to confirm when scan group names are added if they contain characters other than letters, numbers, or spaces.

What this means for you

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 is a Class II medical device recall with no reported injuries or illnesses. The issue is a software user interface limitation where confirmation fails for scan group names containing non-standard characters, which is primarily a functional defect rather than an immediate health or safety hazard.

Plain-English summary

The GE Revolution CT medical imaging system has a user interface defect affecting scan group name configuration. When adding scan group names, the interface requires that names contain only letters, numbers (0-9), or spaces. If other characters are used, the user interface will not update to confirm that the intended group has been added to the acquisition.

The Revolution CT is a computed tomography system used for cross-sectional body imaging. The system is indicated for head, whole body, cardiac, and vascular CT applications and produces diagnostic images from X-ray transmission data.

This is a Class II recall issued by the FDA regarding a software interface limitation affecting device operation.

The recalled product

Product
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs inclu
Manufacturer
GE Healthcare, LLC
Category
Medical Device — CT Scanner
Hazard

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 (1)

  • Revolution CT

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by GE Healthcare, LLC 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 3 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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