Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2639-2025 — ZAP-X Radiosurgery System, Model: 300150

U.S. FDA — Device Enforcement · United States · 2025-07-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2639-2025
Date of alert
2025-07-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zap Surgical Systems
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00860183001504
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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