GE Discovery MR950 MRI Systems Recalled for Missing Laser Labels
GE Healthcare is recalling five Discovery MR950 MRI systems because alignment lasers lack required radiation safety labels.
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 hazard is a missing label rather than a functional defect causing injury, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
GE Healthcare is recalling five units of the Discovery MR950 MRI system. The recall was initiated because the alignment lasers on these systems are missing the labels required by radiation safety regulations.
The affected units were distributed to the state of California in the United States, as well as internationally to Italy and Japan. The recall number for this action is Z-1395-2015.
Consumers and healthcare facilities with these specific MRI systems should contact GE Healthcare for instructions on how to resolve the labeling issue.
The recalled product
- Product
- GE Discovery MR950 MRI system
- Manufacturer
- GE Healthcare
- Category
- Medical Device — MRI System
- Hazard
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 - Discovery MR950
Distribution
Distributed in 1 state:
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