Rover Mobile X-ray System Generator Fastening Mechanism Failure Recall
Five Rover Mobile X-ray Systems are recalled due to a potential failure of the internal fastening mechanism in the X-ray generator. This defect could affect equipment operation in New Jersey, Washington, and Puerto Rico.
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 a FDA Class II medical device recall with no reported injuries or deaths. The hazard is a potential structural failure of the fastening mechanism—a risk-of-harm defect where injury has not yet been reported, meeting the criteria for High severity.
Plain-English summary
The Rover Mobile X-ray System, Model MXU-RV35, manufactured by Micro-X Ltd., is being recalled. This mobile imaging system is designed for acquiring medical diagnostic X-ray images outside a standard X-ray facility and can be used on pediatric and adult patients.
The recall was issued due to a potential failure of the internal fastening mechanism within the X-ray generator. This fastening mechanism failure could affect the proper operation of the equipment.
Five units are affected by this recall and were distributed in New Jersey, Washington, and Puerto Rico. Healthcare providers with affected equipment should verify the serial numbers and contact the manufacturer for remediation instructions.
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.
- Hazard
- fastening-failure
- equipment-malfunction
Distribution
Distributed in 2 states:
- NJ
- WA
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