FDAFDA · Food and drugs·Recall number Z-0665-2025
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Published December 18, 2024 · Recall initiated: November 28, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Micro-X Ltd.
- Distributor
- US Nationwide Distribution: NJ, CA, PR
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Australia
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