Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ZAP-X Radiosurgery System Recalled by Zap Surgical Systems Due to If the radiosurgery system triggers a proximity error...

Date: July 25, 2025
Company: Zap Surgical Systems
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Zap Surgical Systems directly.

Affected Products

ZAP-X Radiosurgery System, Model: 300150

Quantity: 17

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Zap Surgical Systems

Zap Surgical Systems has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report