GE Healthcare Recalls MR Scanners Due to Exposed Foam on End Bells
GE Healthcare is recalling specific MRI scanners because yellow foam on the end bells may extend past the covers. The foam itself is not hazardous, but it may absorb fluids.
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 the foam is not hazardous and no injuries are reported, fitting the criteria for a moderate risk or precautionary recall.
Plain-English summary
GE Healthcare, LLC is recalling the Discovery MR450, Discovery MR750, and Optima MR450w magnetic resonance (MR) scanners. The recall involves 828 units, with 443 located in the United States and 385 outside the U.S. The affected units were distributed worldwide, including in the U.S. (excluding Hawaii, North Dakota, Rhode Island, and Wyoming) and numerous international markets.
The recall is due to a potential safety issue where the yellow foam strip used between the end bell covers and the patient bore may extend past the surface of the covers. While the foam material itself is not hazardous, the exposed foam may absorb fluid or body substances. The source text does not report any illnesses or injuries associated with this defect.
Healthcare facilities should contact GE Healthcare to determine if their specific serial numbers are affected and to arrange for the necessary corrective actions. The recall number is Z-2291-2013.
The recalled product
- Product
- GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa¿ MR 750 System is indicated for use as a diagnostic imaging device to produce axial…
- Manufacturer
- GE Healthcare, LLC
- Hazard
Distribution
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