Reported Apr 23, 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
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
20 of 20 products
Products covered by this recall # Barcodes Product as published 1 09357123000037MSN0348 (01)09357123000037(11)230123(21)00348 2 09357123000037MSN0349 (01)09357123000037(11)230209(21)00349 3 09357123000037MSN0351 (01)09357123000037(11)230413(21)00351 4 09357123000037MSN0359 (01)09357123000037(11)231130(21)00359 5 09357123000037MSN0361 (01)09357123000037(11)230503(21)00361 6 09357123000037MSN0365 (01)09357123000037(11)230510(21)00365 7 09357123000037MSN0391 (01)09357123000037(11)230929(21)00391 8 09357123000037MSN0406 (01)09357123000037(11)240301(21)00406 9 09357123000037MSN0416 (01)09357123000037(11)240429(21)00416 10 09357123000037MSN0419 (01)09357123000037(11)240628(21)00419 11 09357123000037MSN0428 (01)09357123000037(11)240823(21)00428 12 09357123000037MSN0429 (01)09357123000037(11)240823(21)00429 13 09357123000037MSN0430 (01)09357123000037(11)240824(21)00430 14 09357123000037MSN0431 (01)09357123000037(11)240826(21)00431 15 09357123000037MSN0432 (01)09357123000037(11)241108(21)00432 16 09357123000037MSN0434 (01)09357123000037(11)241115(21)00434 17 09357123000037MSN0435 (01)09357123000037(11)241118(21)00435 18 09357123000037MSN0436 (01)09357123000037(11)241122(21)00436 19 09357123000037MSN0437 (01)09357123000037(11)241125(21)00437 20 09357123000037MSN0438 (01)09357123000037(11)250114(21)00438 - Amount recalled
- 20 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 early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
This product could cause temporary or reversible health problems — stop using it.
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