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Zap Surgical Systems recalls ZAP-X Radiosurgery System, Model: 300150
Recalled October 8, 2025 · FDA recall Z-2639-2025 · Zap Surgical Systems
Hazard
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. · FDA Class II
Units
17
Sold at
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.
Description
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
Manufacturer(s)
Zap Surgical Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →