FDA recall, , Moderate risk
Micro-X Rover Mobile X-Ray System
The Rover Mobile X-ray System may malfunction, causing the X-ray to be inoperable.
Summary by Recall Canary from the FDA notice
What happened
Micro-X Ltd. of Tonsley, Australia, recalled the Rover Mobile X-ray System because the X-ray generator may malfunction resulting in the X-ray being inoperable. The recall began on March 27, 2026, and was added to the FDA's Enforcement Report on April 22, 2026.
The recalled units were distributed nationwide in the states and territories of WA, NJ, CA, and Puerto Rico. The FDA classified the recall on April 22, 2026, and the recall was in the FDA's weekly enforcement report on April 29, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number and UDI-DI are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Rover Mobile X-ray System
- Model number
- MXU-RV35
- MXU-RV71
- UDI-DI
- 09357123000051
- 09357123000037
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.
- Company
- Micro-X Ltd.Tonsley, Australia
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98644
- Recall number
- Z-1918-2026
- Quantity recalled
- 32 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
