CLASS II ONGOING Device recall · Reported 5 Oct 2022 · FDA Enforcement Report
Rover Mobile X-ray System, Mxu-rv19 recalled by Micro-X
Micro-X is recalling Micro-x Rover Mobile X-ray System, Mxu-rv19, distributed nationwide in the US. The recall was initiated on 31 Aug 2022 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-1786-2022
- FDA event ID
- 90839
- Recalling firm
- Micro-X, Tonsley, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Aug 2022
- FDA classified
- 23 Sep 2022
- Reported
- 5 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 31 Aug 2022 | Recall initiated by company | |
| 23 Sep 2022 | Classified by FDA | +23 days |
| 5 Oct 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions
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-RV19
Where it was distributed
Worldwide distribution - U.S. Nationwide distribution in the states of CA, NV, NY, OH, TX and WA and the countries of Australia, France, Israel, Japan, and United Arab Emirates.
Questions about this recall
Is Rover Mobile X-ray System, Mxu-rv19 recalled?
Yes. Micro-X recalled Rover Mobile X-ray System, Mxu-rv19 on 31 Aug 2022. The recall is Class II and its status is Ongoing. Recall number Z-1786-2022.
Why was it recalled?
Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions
Which lots are affected?
Model Number: MXU-RV19 UDI Codes: (01)09357123000013(11)210326(21)00222 (01)09357123000013(11)210628(21)00234 (01)09357123000013(11)210629(21)00235 (01)09357123000013(11)210629(21)00236 (01)09357123000013(11)210630(21)00237 (01)09357123000013(11)210708(21)00238 (01)09357123000013(11)210721(21)00240 (01)09357123000013(11)210910(21)00261 (01)09357123000013(11)210913(21)00262 (01)09357123000013(11)210914(21)00263 (01)09357123000013(11)210921(21)00264 (01)09357123000013(11)210922(21)00265 (01)09357123000013(11)210923(21)00266 (01)09357123000013(11)210927(21)00267 (01)09357123000013(11)211006(21)00268 (01)09357123000013(11)211008(21)00269 (01)09357123000013(11)211011(21)00270 (01)09357123000013(11)211011(21)00271 (01)09357123000013(11)211012(21)00272 (01)09357123000013(11)211013(21)00273 (01)09357123000013(11)211013(21)00274 (01)09357123000013(11)211210(21)00288 (01)09357123000013(11)211213(21)00289 (01)09357123000013(11)211213(21)00290 (01)09357123000013(11)220329(21)00305 (01)09357123000013(11)220330(21)00306 (01)09357123000013(11)220331(21)00307 (01)09357123000013(11)220401(21)00308 (01)09357123000013(11)220404(21)00309 (01)09357123000013(11)220405(21)00310 (01)09357123000013(11)220406(21)00311 (01)09357123000013(11)220404(21)00312 Serial Numbers: 222 234 235 236 237 238 240 261 262 263 264 265 266 267 268 269 270 271 272 273 274 288 289 290 305 306 307 308 309 310 311 312
Where was it sold?
Worldwide distribution - U.S. Nationwide distribution in the states of CA, NV, NY, OH, TX and WA and the countries of Australia, France, Israel, Japan, and United Arab Emirates.
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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