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

Rover Mobile X-ray System MXU-RV35 Early X-ray Tube Failure Risk

Micro-X Ltd. is recalling the Rover Mobile X-ray System (model MXU-RV35) due to the potential for early X-ray tube failure caused by excessive thermal load on the anode. The affected units were distributed nationwide in California, New Jersey, and Puerto Rico.

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: The FDA classified this recall as Class II. The source text does not report any injuries or illnesses resulting from the X-ray tube failure, making this a risk-of-harm situation where the potential for device malfunction is identified but actual adverse events have not occurred, consistent with a High severity rating.

Plain-English summary

Micro-X Ltd. is recalling the Rover Mobile X-ray System, model MXU-RV35, a mobile imaging device designed for acquiring medical diagnostic X-ray images outside a standard X-ray room. The system incorporates a self-contained X-ray generator, imaging display, and software for digital radiography and is used in pediatric and adult patient treatment areas for disease and injury detection, diagnosis, and treatment planning.

The recall is being issued because the X-ray tube in the affected units may fail earlier than intended due to excessive thermal load on the anode. This defect could impact the system's ability to function reliably for medical imaging procedures.

Twenty units of the Rover Mobile X-ray System were distributed nationwide in California, New Jersey, and Puerto Rico. The affected serial numbers are: MSN0348, MSN0349, MSN0351, MSN0359, MSN0361, MSN0365, MSN0391, MSN0406, MSN0416, MSN0419, MSN0428, MSN0429, MSN0430, MSN0431, MSN0432, MSN0434, MSN0435, MSN0436, MSN0437, and MSN0438.

Facilities that have received this device should contact Micro-X Ltd. for further instructions regarding repair, replacement, or return of the affected units.

The recalled product

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 — Diagnostic Imaging / X-ray Equipment
Hazard
  • device-malfunction
  • thermal-stress

Is your product affected?

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

Distribution

Distributed nationwide across the United States.

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