The Recall Desk
HighFDA (Devices)·Z-0680-2017·Announced 2016-12-14

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.

What this means for you

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
Category
Medical Device — Analytical Instrument
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

Distributed in 16 states:

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