Medical device recalls Moderate risk

Olympus Scientific Solutions Americas recalls Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System

Recall date
October 27, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0680-2017
FDA classification
Class II
Brand / firm
Olympus Scientific Solutions Americas
Sold / distributed
US Distribution to the states of : TX, WA, GA, MA, SC, AZ, PA, VA, CA, OH, NJ, MD, CO, IL, LA, and MN.

Why it was recalled

Possible unintentional x-ray emission after users attempt early termination of the sequence.

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) Model: VANTA Analytical X-Ray System

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