CLASS II ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report
Rover Mobile X-ray System, # MXU-RV35 recalled by Micro-X
Micro-X is recalling Micro-x Rover Mobile X-ray System, # Mxu-RV35, distributed in California, Maryland, Puerto Rico, Texas. The recall was initiated on 22 Oct 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0580-2025
- FDA event ID
- 95624
- Recalling firm
- Micro-X, Tonsley
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Oct 2024
- FDA classified
- 27 Nov 2024
- Reported
- 4 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 22 Oct 2024 | Recall initiated by company | |
| 27 Nov 2024 | Classified by FDA | +36 days |
| 4 Dec 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Where it was distributed
US: TX, PR, MD, CA
Questions about this recall
Is Rover Mobile X-ray System, # MXU-RV35 recalled?
Yes. Micro-X recalled Rover Mobile X-ray System, # MXU-RV35 on 22 Oct 2024. The recall is Class II and its status is Ongoing. Recall number Z-0580-2025.
Why was it recalled?
Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.
Which lots are affected?
UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391
Where was it sold?
US: TX, PR, MD, CA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Micro-X
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Rover Mobile X-ray System recalled by Micro-X | Micro-X | Device Malfunction | Nationwide |
| Device | CLASS II | Rover Mobile X-ray System recalled by Micro-X | Micro-X | Device Malfunction | NJ, PR, WA |
| Device | CLASS II | Rover Mobile X-ray System recalled by Micro-X | Micro-X | Device Malfunction | NJ, PR, WA |
| Device | CLASS II | Rover Mobile X-ray System recalled by Micro-X | Micro-X | Device Malfunction | Nationwide |
| Device | CLASS II | Rover Mobile X-ray System recalled by Micro-X | Micro-X | Device Malfunction | Nationwide |
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| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled | Canon Medical System, USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
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