Class II — Zap Surgical Systems
| Recalling firm | Zap Surgical Systems Inc. |
|---|---|
| Registered facility | ZAP SURGICAL SYSTEMS INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 speed, a software defect could potentially lead the collimator to collide with patient shoulders or the patient table. |
| Product | ZAP-X Radiosurgery System, Model: 300150 |
| Quantity | 17 |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, CO, NJ, NY and the countries of Germany, France, Spain, Poland, Republic of Korea, Trkiye, Paraguay. |
| Initiated | 2025-07-25 |
| Classified | 2025-09-26 |
| Recall number | Z-2639-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Zap Surgical Systems (Z-2639-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97413/
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