GE Healthcare Recalls Revolution CT Scanners Due to Missing Quality Control Test
GE Healthcare is recalling 13 Revolution CT scanners because a required quality control test was not performed during installation.
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: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a procedural oversight.
Plain-English summary
GE Healthcare is recalling 13 units of the Revolution CT scanner. The Revolution CT is a multi-slice (256 detector row) CT scanner that includes a gantry, patient table, scanner desktop, system cabinet, power distribution unit, and interconnecting cables. The system also includes image acquisition hardware, software, and associated accessories.
The recall is being conducted because a required quality control test was not performed during installation associated with the software of the Revolution CT scanner. The affected software version is 14MW14.29.
The affected units were distributed in the United States to the states of California, Florida, Illinois, New York, Utah, and Washington. Consumers and healthcare facilities should contact GE Healthcare for further instructions regarding the recall.
The recalled product
- Product
- The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition…
- Manufacturer
- GE Healthcare
- Hazard
- Affected units
- 13
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)
- Software version: 14MW14.29
Distribution
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