Eden Prairie, MN, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2024-07-18 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-05-09 | Class II | Ongoing | Z-2235-2023 | vRad PACS with Mammography | — | The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist. |