FDA-Device2015-02-18Class II

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

Virtual Imaging, Inc.
Hazard

There is a potential for unintended and erratic motion.

Sold states
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.
Affected count
316 (US) 6 (Foreign)
Manufactured in
5600 Broken Sound Blvd., 2nd Flr., Boca Raton, FL, United States
Products
Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1064-2015

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