FDA-Device2025-10-08Class II
ZAP-X Radiosurgery System, Model: 300150
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.
Sold states
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.
Affected count
17
Manufactured in
590 Taylor Way, N/A, San Carlos, CA, United States
Products
ZAP-X Radiosurgery System, Model: 300150
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2639-2025Want us to check the next one for you?
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