Class II — Micro-X Ltd.
| Recalling firm | MICRO-X LTD |
|---|---|
| Registered facility | MICRO-X LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| Product | MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 |
| Quantity | 42 units |
| Distribution | 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. |
| Initiated | 2022-08-31 |
| Classified | 2022-09-23 |
| Recall number | Z-1786-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Micro-X Ltd. (Z-1786-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90839/
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