Micro-X Ltd.
Micro-X Ltd. has 10 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-1918-2026 · Class II · Mar 27, 2026
- Latest inspection
- May 23, 2024 · OAI
- Latest 510(k)
- May 21, 2021
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 10 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 2 | Oct 4, 2026 | Not stated | Current |
| Inspections | 1 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1918-2026 | Class II | Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71 | Mar 27, 2026 |
| Z-1669-2025 | Class II | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35… | Apr 4, 2025 |
| Z-1670-2025 | Class II | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product… | Apr 4, 2025 |
| Z-1578-2025 | Class II | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product… | Mar 28, 2025 |
| Z-1579-2025 | Class II | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product… | Mar 28, 2025 |
| Z-0666-2025 | Class II | MICRO-X Rover Mobile X-ray System, # MXU-RV19 | Oct 23, 2024 |
| Z-0580-2025 | Class II | MICRO-X Rover Mobile X-ray System, # MXU-RV35 | Oct 22, 2024 |
| Z-0665-2025 | Class II | MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71 | Nov 28, 2023 |
| Z-0664-2025 | Class II | MICRO-X Rover Mobile X-ray System, # MXU-RV35 | May 31, 2023 |
| Z-1786-2022 | Class II | MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 | Aug 31, 2022 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 23, 2024 | Tonsley, Australia | Devices | Official Action Indicated (OAI) | 3012855798 |