HighFDA (Devices)·Z-1579-2025·Announced 2025-04-23

[pending] Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Descri

Pending LLM rewrite. Source: FDA_DEVICE Z-1579-2025.

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: Pending LLM scoring against the rubric.

Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.

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 diagn
Manufacturer: Micro-X Ltd.
Category: Medical Device — Devices

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Serial Number/UDI: MSN0348 (01)09357123000037(11)230123(21)00348
MSN0349 (01)09357123000037(11)230209(21)00349
MSN0351 (01)09357123000037(11)230413(21)00351
MSN0359 (01)09357123000037(11)231130(21)00359
MSN0361 (01)09357123000037(11)230503(21)00361
MSN0365 (01)09357123000037(11)230510(21)00365
MSN0391 (01)09357123000037(11)230929(21)00391
MSN0406 (01)09357123000037(11)240301(21)00406
MSN0416 (01)09357123000037(11)240429(21)00416
MSN0419 (01)09357123000037(11)240628(21)00419
MSN0428 (01)09357123000037(11)240823(21)00428
MSN0429 (01)09357123000037(11)240823(21)00429
MSN0430 (01)09357123000037(11)240824(21)00430
MSN0431 (01)09357123000037(11)240826(21)00431
MSN0432 (01)09357123000037(11)241108(21)00432
MSN0434 (01)09357123000037(11)241115(21)00434
MSN0435 (01)09357123000037(11)241118(21)00435
MSN0436 (01)09357123000037(11)241122(21)00436
MSN0437 (01)09357123000037(11)241125(21)00437
MSN0438 (01)09357123000037(11)250114(21)00438

Distributed nationwide across the United States.

Same category