Device product
Juno DFR X-ray system
Z-1079-2015
Product summary
- Event
- Event 70241
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 units distributed in the US
- Official record key
device-enforcement:Z-1079-2015
Official wording
Reason: The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality
Code information: P/N 709020
Distribution pattern: 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.
Derived failure modes
-
Unknown
The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality