ZAP-X Radiosurgery System — Class II medical device recall Z-2639-2025
Ongoing recall by Zap Surgical Systems, reported 2025-10-08, distributed nationwide. If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degre
| Recall number | Z-2639-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zap Surgical Systems, San Carlos, CA, United States |
| Recall initiated | 2025-07-25 |
| Classified | 2025-09-26 |
| Reported by FDA | 2025-10-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, ES, FR, KR, PL, PY |
| Quantity | 17 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00860183001504 |
| Serial numbers | ZUC17153, ZUC20156, ZUC20157, ZUC20159, ZUC21162, ZUC21164, ZUC22166, ZUC22169, ZUC22170, ZUC22171, ZUC22173, ZUC22174, ZUC23176, ZUC23177, ZUC24179, ZUC24180, ZUC24181 |
| Model numbers | 300150 |
Product
ZAP-X Radiosurgery System, Model: 300150
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 speed, a software defect could potentially lead the collimator to collide with patient shoulders or the patient table.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2639-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.