HighFDA (Devices)·Z-1578-2025·Announced 2025-04-23

[pending] Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Descri

Pending LLM rewrite. Source: FDA_DEVICE Z-1578-2025.

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-RV71 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: MSN0334 (01)09357123000051(11)220921(21)00334
MSN0350 (01)09357123000037(11)230328(21)00350
MSN0352 (01)09357123000051(11)230823(21)00352
MSN0364 01)09357123000051(11)230705(21)00364
MSN0382 (01)09357123000051(11)230809(21)00382
MSN0383 (01)09357123000051(11)230814(21)00383
MSN0384 (01)09357123000051(11)230816(21)00384
MSN0385 (01)09357123000051(11)230906(21)00385
MSN0386 (01)09357123000051(11)230908(21)00386
MSN0387 (01)09357123000051(11)230914(21)00387
MSN0388 (01)09357123000051(11)230916(21)00388
MSN0389 (01)09357123000051(11)230918(21)00389
MSN0390 (01)09357123000051(11)231013(21)00390
MSN0395 (01)09357123000051(11)231106(21)00395
MSN0397 (01)09357123000051(11)231118(21)00397
MSN0399 (01)09357123000051(11)240122(21)00399
MSN0400 (01)09357123000051(11)240207(21)00400
MSN0401 (01)09357123000051(11)240131(21)00401
MSN0402 01)09357123000051(11)240202(21)00402
MSN0403 (01)09357123000051(11)240205(21)00403

Distributed nationwide across the United States.

Same category