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 | Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up. |
| Product | MICRO-X Rover Mobile X-ray System, # MXU-RV35 |
| Quantity | 6 |
| Distribution | US: TX, PR, MD, CA |
| Initiated | 2024-10-22 |
| Classified | 2024-11-27 |
| Recall number | Z-0580-2025 |
| 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-0580-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95624/
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