MICRO-X Rover Mobile X-ray System Exposure Timing Defect Recalled
Micro-X Ltd. is recalling five MICRO-X Rover Mobile X-ray Systems due to a timing defect that prevents adequate X-ray exposures. The 4 millisecond exposure time does not allow sufficient tolerance for diagnostic-quality imaging.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical imaging device with no reported injuries or illnesses. The hazard is a timing defect causing inadequate X-ray exposures, which affects diagnostic image quality. Per the severity rubric, this meets criteria for High (3) as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Micro-X Ltd. is recalling five MICRO-X Rover Mobile X-ray Systems (Model MXU-RV35) due to a timing defect in the X-ray exposure control system. The mAs integrator terminates X-ray shots, but the 4 millisecond exposure time does not allow sufficient tolerance to achieve diagnostic-quality images.
The issue stems from variations in hardware and differences in how different timers are started, resulting in inadequate X-ray exposures. Five units with serial numbers 00334, 00348, 00349, 00351, and 00361 are affected. The systems have been distributed worldwide, including across the United States in New Jersey, Puerto Rico, and California.
Healthcare facilities using affected units should contact Micro-X Ltd. for information about repair or replacement options. Users should verify that their unit's serial number matches one of the recalled models before continuing use.
Inadequate X-ray exposures may require repeat imaging procedures or result in diagnostic images of insufficient quality. Affected facilities are urged to coordinate with Micro-X Ltd. to resolve the issue promptly.
The recalled product
- Product
- MICRO-X Rover Mobile X-ray System, # MXU-RV35
- Manufacturer
- Micro-X Ltd.
- Hazard
- inadequate-exposure
- timing-defect
- diagnostic-quality-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI: 9357123000037. Serial Numbers: 00334
- 00348
- 00349
- 00351
- 00361.¿
Distribution
Distributed nationwide across the United States.
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