Drug recall
ZAP-X Radiosurgery System, Model: 300150
FDA recall event 97413 · Class II · Zap Surgical Systems
Key facts
| Event ID | 97413 |
|---|---|
| Recall numbers | Z-2639-2025 |
| Recalling firm | Zap Surgical Systems |
| Product type | Devices |
| Products | ZAP-X Radiosurgery System, Model: 300150 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automatic reduction of… |
| Initiation date | Jul 25, 2025 |
| Report date | Oct 8, 2025 |
| City | San Carlos |
| State | CA |
| Country | United States |
| FEI number | 3012039133 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: