Zap Surgical Systems recalls ZAP-X Radiosurgery System, Model: 300150

Recall date

July 25, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2639-2025

FDA classification

Class II

Brand / firm

Zap Surgical Systems

Sold / distributed

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.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ZAP-X Radiosurgery System, Model: 300150