Reported Jul 8, 2015 · Terminated

Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and…

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?

  • Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Lot codes and dates
  • Catalog/Part Number
    • 10000
    • Serial #'s: 100
    • 101
    • and 102
Amount recalled
3

Where it was sold

Why it was recalled

The software was failing to determine new patient locations if imaging is not enabled during treatment.

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 4, 2016 · Data as of Sep 19, 4:49 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.