FDA Enforcement
Class II
Ongoing
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Recall: Z-0665-2025
·
Reported December 18, 2024
Enforcement
- Recall Number
- Z-0665-2025
- Event ID
- 95617
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Micro-X Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 18, 2024
- Initiation Date
- November 28, 2023
- Classification Date
- December 12, 2024
- Address
- Unit 14 6 Mab Eastern Promenade, Tonsley, N/A, Australia
Description
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Reason
Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
Code Info
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
US Nationwide Distribution: NJ, CA, PR
Quantity
18