Zap Surgical Systems: Device Recall
Recall #Z-2639-2025 · 07/25/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2639-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Zap Surgical Systems
- Status
- Ongoing
- Date Initiated
- 07/25/2025
- Location
- San Carlos, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17
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.
Product Description
ZAP-X Radiosurgery System, Model: 300150
Distribution Pattern
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.