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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

Micro-X Rover Mobile X-ray Systems Recalled for Radiation Delivery Error

Agency Publication Date: December 12, 2024
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Summary

Micro-X Ltd. is recalling 18 Rover Mobile X-ray Systems (models MXU-RV35 and MXU-RV71) because the devices may deliver a lower radiation dose than the operator selected. This issue is specific to units equipped with a control board part number PCBA 12425-03 or earlier. There have been no reported incidents or injuries associated with this defect at this time.

Risk

The system may deliver less radiation than intended for a diagnostic image, which can result in poor image quality. This potentially leads to misdiagnosis or requires the patient to be exposed to additional radiation for a repeat x-ray scan.

What You Should Do

  1. This recall affects MICRO-X Rover Mobile X-ray System models MXU-RV35 and MXU-RV71 that use Control Board PCBA 12425-03 or earlier. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled device immediately.
  3. Contact Micro-X Ltd. or your equipment distributor to arrange for a return, replacement, or technical correction of the system.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have further questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: MICRO-X Rover Mobile X-ray System
Model / REF:
MXU-RV35
MXU-RV71
Serial Numbers:
MSN00334
MSN00348
MSN00349
MSN00351
MSN00352
MSN00361
MSN00364
MSN00365
MSN00382
MSN00383
MSN00384
MSN00385
MSN00386
MSN00387
MSN00388
MSN00390
MSN00391
MSN00395
UDI:
9357123000037
935712300005

Affected units use Control Board PCBA, 12425-03 (or earlier).

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95617
Status: Active
Manufacturer: Micro-X Ltd.
Sold By: Medical device distributors; Hospitals; Healthcare facilities
Manufactured In: Australia
Units Affected: 18
Distributed To: New Jersey, California, 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.