CLASS II ONGOING Device recall · Reported 23 Apr 2025 · 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 28 Mar 2025 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-1578-2025
- FDA event ID
- 96518
- Recalling firm
- Micro-X, Tonsley
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Mar 2025
- FDA classified
- 16 Apr 2025
- Reported
- 23 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 28 Mar 2025 | Recall initiated by company | |
| 16 Apr 2025 | Classified by FDA | +19 days |
| 23 Apr 2025 | 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
Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
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
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
Where it was distributed
US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory).
Questions about this recall
Is Rover Mobile X-ray System recalled?
Yes. Micro-X recalled Rover Mobile X-ray System on 28 Mar 2025. The recall is Class II and its status is Ongoing. Recall number Z-1578-2025.
Why was it recalled?
Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
Which lots are affected?
Serial Number/UDI: MSN0334 (01)09357123000051(11)220921(21)00334; MSN0350 (01)09357123000037(11)230328(21)00350 ; MSN0352 (01)09357123000051(11)230823(21)00352; MSN0364 01)09357123000051(11)230705(21)00364; MSN0382 (01)09357123000051(11)230809(21)00382; MSN0383 (01)09357123000051(11)230814(21)00383; MSN0384 (01)09357123000051(11)230816(21)00384; MSN0385 (01)09357123000051(11)230906(21)00385; MSN0386 (01)09357123000051(11)230908(21)00386; MSN0387 (01)09357123000051(11)230914(21)00387; MSN0388 (01)09357123000051(11)230916(21)00388; MSN0389 (01)09357123000051(11)230918(21)00389; MSN0390 (01)09357123000051(11)231013(21)00390; MSN0395 (01)09357123000051(11)231106(21)00395; MSN0397 (01)09357123000051(11)231118(21)00397; MSN0399 (01)09357123000051(11)240122(21)00399; MSN0400 (01)09357123000051(11)240207(21)00400; MSN0401 (01)09357123000051(11)240131(21)00401; MSN0402 01)09357123000051(11)240202(21)00402; MSN0403 (01)09357123000051(11)240205(21)00403; MSN0405 (01)09357123000051(11)240206(21)00405; MSN0408 (01)09357123000051(11)240308(21)00408; MSN0409 (01)09357123000051(11)240312(21)00409; MSN0410 (01)09357123000051(11)240318(21)00410; MSN0411 (01)09357123000051(11)240319(21)00411; MSN0422 (01)09357123000051(11)240724(21)00422; MSN0423 (01)09357123000051(11)240808(21)00423; MSN0424 (01)09357123000051(11)240809(21)00424; MSN0425 (01)09357123000051(11)240812(21)00425; MSN0426 (01)09357123000051(11)240812(21)00426; MSN0427 (01)09357123000051(11)240812(21)00427;
Where was it sold?
US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory).
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, # MXU-RV19 recalled by Micro-X | Micro-X | Other | Nationwide |
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