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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Rover Mobile X-ray Systems Recalled Due to Potential Tube Failure

Agency Publication Date: April 16, 2025
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Summary

Micro-X Ltd. is recalling 51 units of its Rover Mobile X-ray Systems, specifically models MXU-RV71 and MXU-RV35. These mobile imaging devices are designed to perform medical X-ray examinations in locations outside traditional radiology rooms, but they may experience early failure of the X-ray tube. This issue is caused by an excessive heat load on the anode within the tube, which can stop the device from functioning correctly during clinical use.

Risk

The failure of the X-ray tube during a medical procedure could lead to a loss of imaging capability, potentially resulting in delays in patient diagnosis, surgical planning, or therapy monitoring. While no injuries or incidents have been reported to date, a device failure at a critical moment could impact patient care.

What You Should Do

  1. This recall affects Rover Mobile X-ray Systems, models MXU-RV71 and MXU-RV35, produced by Micro-X Ltd. and distributed nationwide.
  2. Check the serial number on your device label to determine if your unit is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately to avoid potential failure during a clinical procedure.
  4. Contact Micro-X Ltd. or your specialty medical distributor to arrange for a return, replacement, or correction of the affected X-ray system.
  5. Call the FDA's medical device recall line at 1-888-463-6332 for more information or assistance with this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Stop using the recalled product and contact the manufacturer or your distributor to arrange return, replacement, or correction.

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Rover Mobile X-ray System (MXU-RV71)
Model / REF:
MXU-RV71
Serial Numbers:
MSN0334
MSN0350
MSN0352
MSN0364
MSN0382
MSN0383
MSN0384
MSN0385
MSN0386
MSN0387
MSN0388
MSN0389
MSN0390
MSN0395
MSN0397
MSN0399
MSN0400
MSN0401
MSN0402
MSN0403
MSN0405
MSN0408
MSN0409
MSN0410
MSN0411
MSN0422
MSN0423
MSN0424
MSN0425
MSN0426
MSN0427
UDI:
(01)09357123000051(11)220921(21)00334
(01)09357123000037(11)230328(21)00350
(01)09357123000051(11)230823(21)00352
(01)09357123000051(11)230705(21)00364
(01)09357123000051(11)230809(21)00382
(01)09357123000051(11)230814(21)00383
(01)09357123000051(11)230816(21)00384
(01)09357123000051(11)230906(21)00385
(01)09357123000051(11)230908(21)00386
(01)09357123000051(11)230914(21)00387
(01)09357123000051(11)230916(21)00388
(01)09357123000051(11)230918(21)00389
(01)09357123000051(11)231013(21)00390
(01)09357123000051(11)231106(21)00395
(01)09357123000051(11)231118(21)00397
(01)09357123000051(11)240122(21)00399
(01)09357123000051(11)240207(21)00400
(01)09357123000051(11)240131(21)00401
(01)09357123000051(11)240202(21)00402
(01)09357123000051(11)240205(21)00403
(01)09357123000051(11)240206(21)00405
(01)09357123000051(11)240308(21)00408
(01)09357123000051(11)240312(21)00409
(01)09357123000051(11)240318(21)00410
(01)09357123000051(11)240319(21)00411
(01)09357123000051(11)240724(21)00422
(01)09357123000051(11)240808(21)00423
(01)09357123000051(11)240809(21)00424
(01)09357123000051(11)240812(21)00425
(01)09357123000051(11)240812(21)00426
(01)09357123000051(11)240812(21)00427

Quantity: 31 units

Product: Rover Mobile X-ray System (MXU-RV35)
Model / REF:
MXU-RV35
Serial Numbers:
MSN0348
MSN0349
MSN0351
MSN0359
MSN0361
MSN0365
MSN0391
MSN0406
MSN0416
MSN0419
MSN0428
MSN0429
MSN0430
MSN0431
MSN0432
MSN0434
MSN0435
MSN0436
MSN0437
MSN0438
UDI:
(01)09357123000037(11)230123(21)00348
(01)09357123000037(11)230209(21)00349
(01)09357123000037(11)230413(21)00351
(01)09357123000037(11)231130(21)00359
(01)09357123000037(11)230503(21)00361
(01)09357123000037(11)230510(21)00365
(01)09357123000037(11)230929(21)00391
(01)09357123000037(11)240301(21)00406
(01)09357123000037(11)240429(21)00416
(01)09357123000037(11)240628(21)00419
(01)09357123000037(11)240823(21)00428
(01)09357123000037(11)240823(21)00429
(01)09357123000037(11)240824(21)00430
(01)09357123000037(11)240826(21)00431
(01)09357123000037(11)241108(21)00432
(01)09357123000037(11)241115(21)00434
(01)09357123000037(11)241118(21)00435
(01)09357123000037(11)241122(21)00436
(01)09357123000037(11)241125(21)00437
(01)09357123000037(11)250114(21)00438

Quantity: 20 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96518
Status: Active
Manufacturer: Micro-X Ltd.
Sold By: Specialty medical distributors
Manufactured In: Australia
Units Affected: 2 products (31 units; 20 units)
Distributed To: California, New Jersey, Puerto Rico

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.