Olympus VANTA Analytical X-Ray System Recalled for Proximity Shutdown Failure
Olympus is recalling 146 VANTA Analytical X-Ray Systems because they may fail to stop testing when no sample is present.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (X-ray radiation exposure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Olympus Scientific Solutions Americas Corporation is recalling 146 units of the VANTA Analytical X-Ray System, X-Ray Fluorescence. The affected models are the VCR and VMR. These instruments were distributed nationwide in the United States.
The recall is due to a defect where the instruments may fail to stop when a test is initiated and no sample is present. Specifically, the proximity shut down function may fail to end the test under certain specific circumstances.
Consumers and users of these devices should stop using the affected units and contact Olympus Scientific Solutions Americas for further instructions on the recall.
The recalled product
- Product
- Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence
- Manufacturer
- Olympus Scientific Solutions Americas
- Hazard
- Affected units
- 146
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)
- Models : VCR and VMR.
Distribution
Distributed nationwide across the United States.
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