The Recall Desk
HighFDA (Devices)·Z-1670-2025·Announced 2025-04-30

Rover Mobile X-ray System internal fastening mechanism failure risk

Micro-X Ltd. is recalling the Rover Mobile X-ray System (model MXU-RV35) due to a potential failure of the internal fastening mechanism within the generator. Five units distributed in New Jersey, Washington, and Puerto Rico are affected.

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 device involving a risk-of-harm product (potential generator fastening failure in an X-ray system). No illnesses or injuries have been reported, but the hazard carries inherent risk of harm to patients and operators if the fastening mechanism fails during use, making it a High severity risk.

Plain-English summary

Micro-X Ltd. is recalling the Rover Mobile X-ray System, model MXU-RV35, a mobile imaging device used for acquiring medical diagnostic X-ray images outside a standard X-ray room. The recall affects five units that were distributed to facilities in New Jersey, Washington, and Puerto Rico.

The recall is due to a potential for the internal fastening mechanism within the generator to fail. The specific affected serial numbers are 348, 349, 350, 351, and 361.

Facilities that operate the Rover Mobile X-ray System should check their serial numbers against those listed in this recall. Customers should contact Micro-X Ltd. for further instructions regarding the recalled units and remediation options.

The recalled product

Product
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: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 medical diagno
Manufacturer
Micro-X Ltd.
Category
Medical Device — Imaging / X-ray Equipment
Hazard
Affected units
5

Distribution

Distributed in 3 states:

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

Same manufacturer · Micro-X Ltd.

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Same hazard · equipment failure

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