Olympus Vanta XRF Analyzers Recalled for LED Warning Light Failure
Olympus is recalling Vanta VCR and VMR XRF analyzers because the LED warning lights may fail to illuminate during X-ray emission.
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 safety feature failure (warning lights) on a device that emits X-rays, creating a risk of harm without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Olympus Scientific Solutions Americas Corporation is recalling Vanta XRF Analyzers, specifically models Vanta VCR and Vanta VMR. The recall involves 74 units distributed across 22 U.S. states, including Pennsylvania, Massachusetts, and California.
The recall was initiated because it was discovered that under rare circumstances, the LED warning light circuit could fail. If this failure occurs, the LED warning lights will not illuminate while the instrument is emitting X-rays during a test. The test itself runs normally and executes as usual, but the visual warning light remains off.
Consumers who possess these specific models should stop using the devices and contact Olympus Scientific Solutions Americas for further instructions.
The recalled product
- Product
- Olympus Scientific Solutions Americas Corporation ( OSSA ) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems
- Manufacturer
- Olympus Scientific Solutions Americas
- Affected units
- 74
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)
- affects all units.
Distribution
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