Reported Oct 8, 2025 · Ongoing

ZAP-X Radiosurgery System, Model: 300150

Zap Surgical Systems

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zap Surgical Systems · 590 Taylor Way · San Carlos, CA · 94070-6307

Is this the product you have?

  • ZAP-X Radiosurgery System
  • Model300150
Lot codes and dates
  • UDI-DI00860183001504
  • Serial Numbers
    • ZUC17153
    • ZUC20156
    • ZUC20157
    • ZUC20159
    • ZUC21162
    • ZUC21164
    • ZUC22166
    • ZUC22169
    • ZUC22170
    • ZUC22171
    • ZUC22173
    • ZUC22174
    • ZUC23176
    • ZUC23177
    • ZUC24179
    • ZUC24180
    • ZUC24181
  • Software versionTDS V1.10.1
Amount recalled
17

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.