FDA-Device2015-03-18Class II
Juno DFR X-ray system
Villa Radiology Systems LLC
Hazard
The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality
Sold states
US Distribution to the states of: AZ, AL, CA, CO, CT, DC, FL, IA, IL, IN, MI, MD, MS, MA, MO, NY, OH, PA, UT, TN and TX.
Affected count
30 units distributed in the US
Manufactured in
91 Willenbrock Rd Ste B1, N/A, Oxford, CT, United States
Products
Juno DFR X-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1079-2015Don't want to check this manually?
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