The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0695-2021·Announced 2020-12-30

GE Healthcare Recalls Three Revolution CT Systems for Protocoling Errors

GE Healthcare is recalling three Revolution CT systems due to a potential for unintended patient orientation or scan settings when using Intelligent Protocoling.

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: The recall involves a high-risk medical device where a software defect could lead to incorrect scan settings or patient orientation, posing a risk of harm, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

GE Healthcare, LLC is recalling three units of the Revolution CT with Apex Edition CT System. These devices are intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications.

The recall is being conducted because of a potential for protocols with unintended patient orientation or scan settings when using the Intelligent Protocoling feature. The affected units were distributed worldwide, including in the United States (specifically Florida and Texas) and in Belgium, France, and Spain.

Healthcare facilities should contact GE Healthcare for instructions on how to address the issue. The specific serial numbers affected are REVVX1700078CN, 00000440315CN0, and REVVX1800040CN.

The recalled product

Product
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
Hazard
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 (2)

  • Model Number: 5995000-5
  • 00000440315CN0 (System ID: 220078CT04)

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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