The Recall Desk
ModerateFDA (Devices)·Z-1578-2025·Announced 2025-04-23

Rover Mobile X-ray System Recalled for Potential Early Tube Failure

Micro-X Ltd. is recalling 31 Rover Mobile X-ray Systems (Model MXU-RV71) due to potential early life failure of the x-ray tube caused by excessive thermal load on the anode. The systems were distributed nationwide in California, New Jersey, and Puerto Rico.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The hazard is theoretical (potential for early life failure) with no reported injuries or adverse health consequences mentioned in the source text, placing it at the lower end of Class II severity.

Plain-English summary

Micro-X Ltd. is recalling the Rover Mobile X-ray System (Model MXU-RV71), a mobile imaging device used for acquiring medical diagnostic x-ray images outside a standard x-ray room. The recall affects 31 units distributed in California, New Jersey, and Puerto Rico. The device incorporates a self-contained X-ray generator, imaging display, and software, and is designed for use on pediatric and adult patients in various treatment areas.

The recall is due to a potential for early life x-ray tube failure caused by excessive thermal load on the anode. This hazard could compromise the device's ability to perform diagnostic imaging.

Affected serial numbers include MSN0334, MSN0350, MSN0352, MSN0364, MSN0382 through MSN0427 (with specific UDI codes documented). Healthcare facilities and providers using these units should contact Micro-X Ltd. for further instructions regarding service, repair, or device replacement.

No injuries or adverse events have been reported in connection with this issue. Consumers and healthcare providers with questions or concerns should contact the manufacturer or refer to the FDA recall notice.

The recalled product

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 — Diagnostic Imaging / X-ray
Hazard
  • x-ray-tube-failure
  • thermal-damage

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: 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

Distribution

Distributed nationwide across the United States.

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