Recall Z-2639-2025— Zap Surgical Systems

Name: FDA recall Z-2639-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-25

Class II · Ongoing

Class II FDA medical device recall by Zap Surgical Systems, initiated 2025-07-25. It names one FDA 510(k) clearance: K211663. Product: ZAP-X Radiosurgery System, Model: 300150. Reason: 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..

Recalling firm: Zap Surgical Systems
Classification: Class II
Status: Ongoing
Initiated: 2025-07-25
Firm location: San Carlos, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K211663 — Zap-X Radiosurgical SystemZap Surgical Systems, Inc.·cleared 2021-07-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.