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 | Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started. |
| Product | MICRO-X Rover Mobile X-ray System, # MXU-RV35 |
| Quantity | 5 |
| Distribution | Worldwide and US Nationwide Distribution: NJ, PR, CA |
| Initiated | 2023-05-31 |
| Classified | 2024-12-12 |
| Recall number | Z-0664-2025 |
| 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-0664-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95603/
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