Reported Feb 24, 2016 · Terminated

MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.

Viewray Incorporated

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 Incorporated · 2 Thermo Fisher Way · Oakwood Village, OH · 44146-6536

Is this the product you have?

  • MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
Lot codes and dates
    • Model #: 10000
    • Serial #'s: 100
    • 101
    • 102
    • 104 & 105
Amount recalled
5 units

Where it was sold

Why it was recalled

The system loaded a completion fraction in the incorrect order after a treatment interruption.

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 Feb 22, 2017 · Data as of Sep 19, 5:19 PM UTC

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