Rover Mobile X-ray Systems Recall Due to Potential Fastening Mechanism Failure
Micro-X Ltd. is recalling Rover Mobile X-ray Systems (models MXU-RV71, MXU-RV35) due to a potential failure of an internal fastening mechanism in the X-ray generator.
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 Class II recall addresses a risk-of-harm medical device where an internal fastening mechanism in the X-ray generator has potential to fail. No injuries or illnesses have been reported, making the maximum applicable score per the rubric 3 (High) for theoretical risk-of-harm scenarios without reported harm.
Plain-English summary
Micro-X Ltd. is recalling 13 units of the Rover Mobile X-ray System (models MXU-RV71 and MXU-RV35). The Rover is a mobile diagnostic imaging system designed to acquire medical radiographic images outside of a standard X-ray room for use with digital radiography detectors.
The recall has been issued due to a potential for an internal fastening mechanism within the X-ray generator to fail.
The affected units have been distributed in the United States in New Jersey, Washington, and Puerto Rico. Healthcare facilities and technicians with affected equipment should contact Micro-X Ltd. for further information regarding this recall.
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 med
- Manufacturer
- Micro-X Ltd.
- Hazard
- fastening-failure
- equipment-malfunction
Distribution
Distributed in 2 states:
- NJ
- WA
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