FDAFDA · Food and drugs·Recall number Z-0664-2025
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Published December 18, 2024 · Recall initiated: May 31, 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
Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Micro-X Ltd.
- Distributor
- Worldwide and US Nationwide Distribution: NJ, PR, CA
- Lot
- UDI-DI: 9357123000037. Serial Numbers: 00334, 00348, 00349, 00351, 00361.¿
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Australia
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