MICRO-X Rover Mobile X-ray System delivers lower-than-set radiation doses
Micro-X Ltd. is recalling 18 MICRO-X Rover Mobile X-ray Systems because they can deliver lower radiation doses than operators set. The affected units use Control Board PCBA 12425-03 or earlier.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II medical device recall affecting radiation dose delivery accuracy in diagnostic imaging equipment. The defect creates a risk of compromised diagnostic quality due to dosage discrepancy between operator settings and actual delivery. No illnesses, injuries, or hospitalizations are reported in the source.
Plain-English summary
Micro-X Ltd. is recalling 18 MICRO-X Rover Mobile X-ray Systems (models MXU-RV35 and MXU-RV71) distributed nationwide in New Jersey, California, and Puerto Rico. The recalled units contain specific serial numbers and use Control Board PCBA 12425-03 or earlier.
The defect: The system can report and deliver a lower post-exposure mAs (milliampere-second) value than what the operator has set. This results in radiation doses lower than the operator intended.
Healthcare facilities should immediately contact Micro-X Ltd. to identify affected units using the provided serial numbers and arrange for repair, remedy, or replacement. Facilities should verify actual dose output against operator-set values before clinical use.
The recalled product
- Product
- MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
- Manufacturer
- Micro-X Ltd.
- Affected units
- 18
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 (18)
- 12425-03 (or earlier). Serial Numbers: MSN00334
- MSN00348
- MSN00349
- MSN00351
- MSN00352
- MSN00361
- MSN00364
- MSN00365
- MSN00382
- MSN00383
- MSN00384
- MSN00385
- MSN00386
- MSN00387
- MSN00388
- MSN00390
- MSN00391
- MSN00395
Distribution
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