Medical Device Recall: ZAP-X Radiosurgery System, Model: 300150
Zap Surgical Systems · July 25, 2025
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.
States Affected
NATIONWIDE
Quantity Affected
17
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2639-2025
Status: ongoing
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