Micro-X Ltd.
FDA Regulatory Profile
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
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 10 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 2 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | 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 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3012855798 | Tonsley, Australia | 1 | May 23, 2024 |