Olympus Delta XRF Analyzer Recalled Due to Software Bug
Olympus Scientific Solutions Americas is recalling Delta XRF Analyzers because the firm discovered a software bug.
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, which typically indicates a temporary or medically reversible adverse health consequence. As no specific injuries, illnesses, or high-risk hazards are reported in the source text, it falls under the Moderate category for a precautionary software defect.
Plain-English summary
Olympus Scientific Solutions Americas Corporation (OSSA) is recalling the Delta XRF Analyzer, an analytical X-ray system. The recall was initiated after the firm discovered a software bug in the product.
The recall covers all models of the Delta XRF Analyzer. The source text indicates that 5,000 units were distributed in the United States, with a worldwide distribution pattern noted.
The source text does not specify the exact nature of the software bug, the specific risks associated with it, or the recommended actions for consumers. Users of the device should contact the recalling firm for further information regarding the defect and any necessary remediation.
The recalled product
- Product
- Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system
- Manufacturer
- Olympus Scientific Solutions Americas
- Hazard
- Affected units
- 5,000
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)
- All models of the Delta XRF Analyzer
Distribution
Distributed nationwide across the United States.
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