Rover Mobile X-ray System may malfunction and become inoperable
Micro-X Ltd. is recalling certain Rover Mobile X-ray Systems (models MXU-RV35 and MXU-RV71) because the X-ray generator may malfunction, rendering the device inoperable.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a medical device where the hazard is malfunction resulting in device inoperability. No illnesses, injuries, or adverse events are reported in the source text, making this a precautionary recall with a moderate classification.
Plain-English summary
Micro-X Ltd. is recalling Rover Mobile X-ray Systems, models MXU-RV35 and MXU-RV71, distributed nationwide in Washington, New Jersey, California, and Puerto Rico. The X-ray generator in these devices may malfunction, resulting in the X-ray being inoperable.
A total of 32 units have been identified as part of this recall. The affected units are identified by specific serial numbers for each model, which are available through product traceability records maintained by the manufacturer.
Affected users should contact Micro-X Ltd. for guidance on device status and corrective action. Users should not operate affected units until they have been evaluated by the manufacturer.
The recalled product
- Product
- Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
- Manufacturer
- Micro-X Ltd.
- Affected units
- 32
Distribution
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