Z-0665-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2024
- Initiation Date
- November 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18
Product Description
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Reason for Recall
Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
Distribution Pattern
US Nationwide Distribution: NJ, CA, PR
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