CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report
Rover Mobile X-ray System recalled by Micro-X
Micro-X is recalling Rover Mobile X-ray System, distributed nationwide in the US. The recall was initiated on 27 Mar 2026 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-1918-2026
- FDA event ID
- 98644
- Recalling firm
- Micro-X, Tonsley, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Mar 2026
- FDA classified
- 22 Apr 2026
- Reported
- 29 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 27 Mar 2026 | Recall initiated by company | |
| 22 Apr 2026 | Classified by FDA | +26 days |
| 29 Apr 2026 | 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
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
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
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Where it was distributed
US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.
Questions about this recall
Why was it recalled?
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
Which lots are affected?
Lot Code: Refer to product traceability spreadsheet provided MXU-RV71 UDI: (01)09357123000051/ Serial Numbers: 334 397 399 408 423 425 459 MXU-RV35 UDI: (01)09357123000037/ Serial Numbers: 269 223 349 348 351 363 388 384 391 359 416 419 428 429 430 431 435 434 436 413 437 438 460 461 462
Where was it sold?
US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.
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 | 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 |
| Device | CLASS II | Rover Mobile X-ray System, # MXU-RV19 recalled by Micro-X | Micro-X | Other | 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 |