Micro-X Ltd.
FDA Regulatory Profile
Micro-X Ltd. appears in FDA public data with 10 recalls, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1918-2026, Class II) was initiated on March 27, 2026. Its most recent 510(k) clearance was granted on July 17, 2020.
Summary
- Total Recalls
- 10
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1918-2026 | Class II | Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71 | March 27, 2026 |
| Z-1669-2025 | Class II | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Prod | April 4, 2025 |
| Z-1670-2025 | Class II | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Descrip | April 4, 2025 |
| Z-1578-2025 | Class II | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Descri | March 28, 2025 |
| Z-1579-2025 | Class II | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Descri | March 28, 2025 |
| Z-0666-2025 | Class II | MICRO-X Rover Mobile X-ray System, # MXU-RV19 | October 23, 2024 |
| Z-0580-2025 | Class II | MICRO-X Rover Mobile X-ray System, # MXU-RV35 | October 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 | November 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 | August 31, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K201488 | Rover | July 17, 2020 |