# FDA recall Z-2639-2025

> **Zap Surgical Systems** · Class II · device recall initiated 2025-07-25.

## 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.

## Distribution

Worldwide - US Nationwide distribution in the states of FL, CO, NJ, NY and the countries of Germany, France, Spain, Poland, Republic of Korea, T¿rkiye, Paraguay.

## Key facts

- **Recall number:** Z-2639-2025
- **Recalling firm:** Zap Surgical Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-25
- **Report date:** 2025-10-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Carlos, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2639-2025

## Citation

> AI Analytics. FDA recall Z-2639-2025. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-2639-2025. Source: US FDA. Licensed CC0.

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