Reported May 8, 2019 · Terminated

MRIdian Linac Radiation Therapy System, Model 20000.

Viewray, Inc.

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: Viewray, Inc. · 815 E Middlefield Rd · Mountain View, CA · 94043-4025

Is this the product you have?

  • MRIdian Linac Radiation Therapy System, Model 20000.
Lot codes and dates
    • Serial Numbers 101
    • 107
    • 201
    • 202
    • 203
    • 204
    • 205
    • 206
    • 209
    • 211
    • 213
    • 214
    • 217
    • 221
    • 223
    • 225
    • 228
Amount recalled
17 devices

Where it was sold

Why it was recalled

A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.

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

Notice updated Jun 16, 2022 · Data as of Sep 19, 6:57 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.