GE OEC Brivo 865 Plus Mobile X-ray Laser Aimer Assemblies Recalled
GE OEC Medical Systems is recalling nine mobile X-ray laser aimer assemblies because they were shipped without required laser product certification.
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 describes a regulatory compliance issue regarding missing certification rather than a reported injury or high-risk pathogen, fitting the criteria for a moderate severity score.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling nine laser aimer assemblies for the GE OEC Brivo 865 plus Mobile X-ray system. The affected units are identified by part number 520002DW and specific serial numbers: B4S13061, B4S14006, B4S14007, B4S13033, B4S13032, B4S13038, B4S13039, B4S13024, and B4S13023.
The recall was initiated because the laser aimer assemblies were shipped without certification of the overall assembly or the submission of a laser product report. Consequently, these products do not comply with US regulations for laser products.
The affected units were distributed in the United States to the states of Maryland, North Carolina, Montana, New Jersey, Utah, and New York. The source text does not specify the actions consumers or healthcare facilities should take in response to this recall.
The recalled product
- Product
- GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
- Manufacturer
- GE OEC Medical Systems, Inc
- Affected units
- 9
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 (9)
- OEC Brivo 865 Plus serial numbers B4S13061
- B4S14006
- B4S14007
- B4S13033
- B4S13032
- B4S13038
- B4S13039
- B4S13024
- AND B4S13023.
Distribution
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