GE Healthcare Recalls Revolution CT Scanners for Bolted Joint Torque Check
GE Healthcare is recalling 13 Revolution CT scanners to perform a required torque check on three bolted joints. No injuries or illnesses have been reported.
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, but the source explicitly states that no injuries or illnesses have been reported. Per the rubric, a Class II recall without hospitalization reports or significant injury data falls under the 'Moderate' category (Score 2) as a precautionary measure.
Plain-English summary
GE Healthcare is recalling 13 units of the Revolution CT multi-slice (256 detector row) CT scanner. The recall is being conducted to address a potential safety issue involving a required torque check on three bolted joints of the scanner.
The affected units are distributed in the United States (Florida, Washington, Illinois, Utah, New York, and California) and internationally in Canada, France, Hong Kong, Japan, Switzerland, and the United Arab Emirates. The source text explicitly states that no injuries or illnesses have been reported in connection with this recall.
Healthcare facilities should contact GE Healthcare to schedule the necessary torque check on the affected equipment. This action is required to ensure the structural integrity of the bolted joints.
The recalled product
- Product
- GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
- Manufacturer
- GE Healthcare
- Hazard
Distribution
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