Reported Feb 27, 2013 · Terminated

Monaco RTP System. Radiation treatment planning.

Elekta, 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: Elekta, Inc. · 400 Perimeter Center Ter Ne · Atlanta, GA · 30346-1227

Is this the product you have?

  • Monaco RTP System. Radiation treatment planning.
Lot codes and dates
  • Versions 3.20.00 and 3.20.01
Amount recalled
13

Where it was sold

Why it was recalled

The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.

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 Jan 21, 2014 · Data as of Sep 19, 5:26 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.