Micro-X Ltd. Recall 95617
Description: MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Micro-X Ltd. Recall 95617 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0665-2025 |
| Event ID | 95617 |
| Event Description | MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71 |
| Product Type | Devices |
| Distribution | US Nationwide Distribution: NJ, CA, PR |
| Quantity | 18 |
| Recall Reason | Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator. |
| Device Classification | 20241218 |
| Device 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 |
| Center Classification Date | 20241212 |
| Recall Initiation Date | 20231128 |
| Recalling Firm | Micro-X Ltd. |
| Initial Notification | Letter |
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