Reported Dec 18, 2019 · Terminated

MRIdian Linac Radiation Therapy System Model 10000 and 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 10000 and 20000
Lot codes and dates
  • Serial Numbers
    • 100
    • 101
    • 102
    • 103
    • 104
    • 105
    • 107
    • 108
    • 112
    • 113
    • 201
    • 202
    • 203
    • 204
    • 205
    • 206
    • 209
    • 211
    • 213
    • 214
    • 217
    • 221
    • 223
    • 225
  • Device Listing NumberD158423 and D297999
Amount recalled
24 Systems

Where it was sold

Why it was recalled

Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system.

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 Apr 28, 2021 · Data as of Sep 19, 4:51 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.