FDA-Device2017-02-08Class II

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

Olympus Scientific Solutions Americas
Hazard

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.

Sold states
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.
Affected count
US 74
Manufactured in
48 Woerd Ave, N/A, Waltham, MA, United States
Products
Olympus Scientific Solutions Americas Corporation (OSSA) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1036-2017

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