CLASS II ONGOING Device recall · Reported 18 Dec 2024 · FDA Enforcement Report
Rover Mobile X-ray System, # MXU-RV19 recalled by Micro-X
Micro-X is recalling Rover Mobile X-ray System, # MXU-RV19, distributed nationwide in the US. The recall was initiated on 23 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-0666-2025
- FDA event ID
- 95593
- Recalling firm
- Micro-X, Tonsley
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Oct 2024
- 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
| 23 Oct 2024 | Recall initiated by company | |
| 12 Dec 2024 | Classified by FDA | +50 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
During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such that the orange ring of death is displayed in the tube cooling area of the screen. The system then becomes unresponsive to kV/mAs changes, prep/expose presses. The only way to proceed is to suspend the patient, Exit Nexus DR and relogin and continue the exam.
Product as listed by the FDA
MICRO-X Rover Mobile X-ray System, # MXU-RV19
Where it was distributed
US Nationwide Distribution: TX, CA, OH, ID, WA, AZ
Questions about this recall
Why was it recalled?
During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such that the orange ring of death is displayed in the tube cooling area of the screen. The system then becomes unresponsive to kV/mAs changes, prep/expose presses. The only way to proceed is to suspend the patient, Exit Nexus DR and relogin and continue the exam.
Which lots are affected?
UDI-DI: 09357123000013. Serial Numbers: 262, 274, 320, 329, 237, 269, 271, 290, 292, 307, 310, 311, 312, 321, 322, 323, 327, 330, 331, 332, 333, 234, 266.
Where was it sold?
US Nationwide Distribution: TX, CA, OH, ID, WA, AZ
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 26 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 |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |