GE Healthcare Recalls Two Revolution CT ES Units for Protocoling Error
GE Healthcare is recalling two Revolution CT ES units 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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential unintended scan settings.
Plain-English summary
GE Healthcare, LLC is recalling two units of the Revolution CT ES, a medical device intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The recall is due to a potential for protocols with unintended patient orientation or scan settings when using the Intelligent Protocoling feature.
The affected units are distributed worldwide, including in the United States (specifically Florida and Texas) and in Belgium, France, and Spain. The specific serial numbers for the recalled units are REVV81900024CN and REVV81900022CN.
Healthcare facilities should contact GE Healthcare for instructions on how to address the issue. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 2
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)
- Model Number: 5995001-6
Distribution
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.
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