MICRO-X ROVER MOBILE X-RAY SYSTEM — Class II medical device recall Z-1786-2022
Ongoing recall by Micro-X Ltd., reported 2022-10-05, distributed nationwide. Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the produc
| Recall number | Z-1786-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro-X Ltd., Tonsley, N/A, Australia |
| Recall initiated | 2022-08-31 |
| Classified | 2022-09-23 |
| Reported by FDA | 2022-10-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, FR, IL, JP |
| Quantity | 42 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 09357123000013 |
| 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 and 7 more |
| Model numbers | MXU-RV19 |
Product
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1786-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.