Olympus Vanta Analytical X-Ray System Recalled for Unintentional Emission Risk
Olympus is recalling 41 Vanta Analytical X-Ray Systems due to a risk of unintentional x-ray emission if users attempt to terminate the sequence early.
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 unintended radiation exposure, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Olympus Scientific Solutions Americas Corporation (OSSA) is recalling 41 units of the Vanta Analytical X-Ray System (Model: Vanta VCR). The recall is due to a potential safety hazard where unintentional x-ray emission may occur if users attempt to terminate the sequence early.
The affected units were distributed in the United States to the states of Texas, Washington, Georgia, Massachusetts, South Carolina, Arizona, Pennsylvania, Virginia, California, Ohio, New Jersey, Maryland, Colorado, Illinois, Louisiana, and Minnesota.
Users of these systems should stop using the product 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
- Manufacturer
- Olympus Scientific Solutions Americas
- Hazard
- Affected units
- 41
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 - Vanta VCR
Distribution
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