FDA recall Z-2639-2025

Zap Surgical Systems · Class II · device

Product

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.

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.

Key facts

Status
Ongoing
Initiation date
2025-07-25
Report date
2025-10-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Carlos, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2639-2025