Rover Mobile X-ray System internal fastening mechanism failure potential
Micro-X Ltd. is recalling Rover Mobile X-ray System units (models MXU-RV71, MXU-RV35) due to a potential failure of the internal fastening mechanism within the generator. Affected units were distributed in New Jersey, Washington, and Puerto Rico.
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: This is an FDA Class II medical device recall involving a structural/mechanical defect (internal fastening mechanism failure) in diagnostic imaging equipment. The source text does not report any injuries or illnesses, but the potential for the generator component to fail creates a risk of harm in a device used for patient imaging.
Plain-English summary
Micro-X Ltd. is recalling the Rover Mobile X-ray System, models MXU-RV71 and MXU-RV35, due to a potential for internal fastening mechanisms within the generator to fail. The Rover is a mobile imaging system used to perform radiographic X-ray examinations for disease and injury detection, diagnosis, treatment planning, and therapy monitoring, and can be used on both pediatric and adult patients across all patient treatment areas.
A total of 13 units have been identified as affected. The devices were distributed in New Jersey, Washington, and Puerto Rico in the United States.
Facilities and hospitals that have received affected Rover units should stop using the devices and contact Micro-X Ltd. for further instructions regarding replacement or repair. Patients who have concerns about imaging performed on affected units should consult their healthcare provider.
The recalled product
- Product
- Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring…
- Manufacturer
- Micro-X Ltd.
- Affected units
- 13
Distribution
Part of a larger recall action
This product is one of 2 recalled by Micro-X Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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