Agency classClass IIOur severity:High FDA (Devices)·Z-1129-2021·Announced 2021-02-24

GE Healthcare Recalls Revolution CT Systems Due to Table Pinch Protector Issue

GE Healthcare is recalling 96 Revolution CT systems because a damaged or missing table pinch protector may expose sharp screws, posing a laceration risk.

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 risk-of-harm product (laceration from sharp edges) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

GE Healthcare, LLC is recalling 96 units of Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems. The recall is due to a potential issue where the table pinch protector could be damaged or missing. This condition may lead to exposed table screws with sharp edges.

The affected units were distributed worldwide, including nationwide distribution in the United States and in numerous international countries. The specific model numbers and serial numbers for the affected units are listed in the official recall documentation.

The exposed screws present a risk of laceration due to their sharp edges. No specific instructions for consumers are provided in the source text, but the recall is intended to address the safety hazard associated with the table pinch protector.

The recalled product

Product: System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Imaging Equipment
Hazard: laceration
sharp-edge
Affected units: 96

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)

Model Numbers: 5590000-20: REV2A1900002CN
REV2A2000013CN
REV2A2000025CN
REV2A2000006CN
REV2A2000003CN
REV2A2000015CN
REV2A1900003CN
REV2A2000007CN
REV2A2000022CN
REV2A2000010CN
REV2A2000030CN
REV2A2000029CN
REV2A2000017CN
REV2A2000001CN
REV2A2000002CN
REV2A2000031CN
REV2A2000020CN
REV2A2000024CN
REV2A2000023CN
REV2A2000012CN

Distribution

Distributed nationwide across the United States.

The notice also names 39 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 →

Same manufacturer · GE Healthcare, LLC

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Same hazard · laceration