Reported Apr 30, 2025 · Ongoing
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover…
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-RV71
- MXU-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) 352 (01)09357123000051(11)230823(21)00352 334 (01)09357123000051(11)220921(21)00334 389 (01)09357123000051(11)230814(21)00383 383 (01)09357123000051(11)230814(21)00383 384 (01)09357123000051(11)230816(21)00384 382 (01)09357123000051(11)230809(21)00382 386 (01)09357123000051(11)230908(21)00386 385 (01)09357123000051(11)230906(21)00385 387 (01)09357123000051(11)230914(21)00387 388 (01)09357123000051(11)230916(21)00388 364 01)09357123000051(11)230705(21)00364 390 (01)09357123000051(11)231013(21)00390 395 (01)09357123000051(11)231106(21)00395
- Amount recalled
- 13 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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