Device product
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Z-0665-2025
Product summary
- Firm
- Micro-X Ltd.
- Event
- Event 95617
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18
- Official record key
device-enforcement:Z-0665-2025
Official wording
Reason: Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
Code information: MXU-RV35 UDI-DI: 9357123000037 and MXU-RV71 UDI-DI: 935712300005 using Control Board PCBA, 12425-03 (or earlier). Serial Numbers: MSN00334, MSN00348, MSN00349, MSN00351, MSN00352, MSN00361, MSN00364, MSN00365,MSN00382, MSN00383, MSN00384, MSN00385, MSN00386, MSN00387, MSN00388, MSN00390, MSN00391, MSN00395
Distribution pattern: US Nationwide Distribution: NJ, CA, PR
Derived failure modes
-
Unknown
Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.