Reported Apr 30, 2025 · Ongoing
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile…
Micro-X Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Micro-X Ltd. · Unit 14 6 Mab Eastern Promenade · Tonsley, N/A · N/A
Is this the product you have?
- Brand NameRover
- Product NameMobile
- X-ray System Model/Catalog NumberMXU-RV35
- Product DescriptionRover 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 diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in
- all patient treatment areas ComponentN/A
- Lot codes and dates
- Serial Number/UDI-DI - 349 (01)09357123000037(11)230209(21)00349 348 (01)09357123000037(11)230123(21)00348 350 (01)09357123000037(11)230328(21)00350. 351 (01)09357123000037(11)230413(21)00351 361 (01)09357123000037(11)230503(21)00361
- Amount recalled
- 5 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
This product could cause temporary or reversible health problems — stop using it.
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