CLASS II ONGOING Device recall · Reported 18 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 nationwide in the US. The recall was initiated on 28 Nov 2023 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-0665-2025
- FDA event ID
- 95617
- Recalling firm
- Micro-X, Tonsley
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Nov 2023
- FDA classified
- 12 Dec 2024
- Reported
- 18 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 28 Nov 2023 | Recall initiated by company | |
| 12 Dec 2024 | Classified by FDA | +380 days |
| 18 Dec 2024 | Published in enforcement report | +6 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 can report and deliver a lower post-exposure mAs value than what set by the operator.
Product as listed by the FDA
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Where it was distributed
US Nationwide Distribution: NJ, CA, PR
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 28 Nov 2023. The recall is Class II and its status is Ongoing. Recall number Z-0665-2025.
Why was it recalled?
Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
Which lots are affected?
MXU-RV35 UDI-DI: 9357123000037 and MXU-RV71 UDI-DI: 935712300005 using Control Board PCBA, 12425-03 (or earlier). Serial Numbers: MSN00334, MSN00348, MSN00349, MSN00351, MSN00352, MSN00361, MSN00364, MSN00365,MSN00382, MSN00383, MSN00384, MSN00385, MSN00386, MSN00387, MSN00388, MSN00390, MSN00391, MSN00395
Where was it sold?
US Nationwide Distribution: NJ, CA, PR
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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