MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
This recall is currently active, issued December 12, 2024. It was issued by Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia.
- Recall Initiated
- November 28, 2023
- Posted
- December 12, 2024
- Recall Number
- Z-0665-2025
- Quantity
- 18
- Official Source
- View on FDA website ↗
Reason for Recall
Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
Distribution
US Nationwide Distribution: NJ, CA, PR
Lot / 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
Root Cause
Device Design
Action Taken
On 11/28/23 Modification 17 was sent to customers telling them that Control Boards need to be replaced with Control Board PCBA, 12425-04 that will eliminate the issue. For technical assistance contact: support-us@micro-x.com, 1-206-249-8764 Firm asked distributors to do the following: On next visit please confirm that the bulletins were completed and return the documentation.