San Carlos, CA, US · 2 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| IYE | — | — | — | 2 | 2025-11-03 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-07-25 | Class II | Ongoing | Z-2639-2025 | ZAP-X Radiosurgery System, Model: 300150 | — | If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occu… |
| 2022-07-05 | Class II | Ongoing | Z-1742-2022 | ZAP-X Radiosurgery System | — | Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally reconstru… |