Medical device recalls Moderate risk

Olympus Scientific Solutions Americas recalls Olympus Scientific Solutions Americas Corporation (OSSA) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytica…

Recall date
January 7, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1036-2017
FDA classification
Class II
Brand / firm
Olympus Scientific Solutions Americas
Sold / distributed
US Distribution to the states of : PA, MA, CO, OH, NJ, GA, CA, TX, IL, VA, MN, NH, WA, SC, AZ, LA, MD, OK, IN, NY, NC and KS.

Why it was recalled

It was discovered under rare circumstances the LED warning light circuit could fail. If this happens, while the instrument is emitting X-rays during at test, the LED warning lights will not illuminate. The test runs normally and will execute as before, but the light will not be on.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Olympus Scientific Solutions Americas Corporation (OSSA) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems

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