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Villa Radiology Systems LLC recalls Juno DFR X-ray system
Recalled March 18, 2015 · FDA recall Z-1079-2015 · Villa Radiology Systems
Hazard
The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality · FDA Class II
Units
30 units distributed in the US
Sold at
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.
Description
The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality
Product
Juno DFR X-ray system
Manufacturer(s)
Villa Radiology Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →