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 | During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such that the orange ring of death is displayed in the tube cooling area of the screen. The system then becomes unresponsive to kV/mAs changes, prep/expose presses. The only way to proceed is to suspend the patient, Exit Nexus DR and relogin and continue the exam. |
| Product | MICRO-X Rover Mobile X-ray System, # MXU-RV19 |
| Quantity | 23 |
| Distribution | US Nationwide Distribution: TX, CA, OH, ID, WA, AZ |
| Initiated | 2024-10-23 |
| Classified | 2024-12-12 |
| Recall number | Z-0666-2025 |
| 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-0666-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95593/
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