Medical device recalls Moderate risk

Virtual Imaging, Inc. recalls Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.

Recall date
September 22, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1064-2015
FDA classification
Class II
Brand / firm
Virtual Imaging, Inc.
Sold / distributed
USA (nationwide) to the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV) + US Army facility in South Korea; and the country of Canada.

Why it was recalled

There is a potential for unintended and erratic motion.

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

What was recalled

Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.

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