ZAP-X Radiosurgery System, Model: 300150
Reported: October 8, 2025 Initiated: July 25, 2025 #Z-2639-2025
Product Description
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.
Details
- Recalling Firm
- Zap Surgical Systems
- Units Affected
- 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, T¿rkiye, Paraguay.
- Location
- San Carlos, CA
Frequently Asked Questions
What product was recalled? ▼
ZAP-X Radiosurgery System, Model: 300150. Recalled by Zap Surgical Systems. Units affected: 17.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 8, 2025. Severity: Moderate. Recall number: Z-2639-2025.
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