Reported Mar 6, 2019 · Terminated

Monaco Radiation Treatment Planning (RTP) System

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 Ste 50 · Atlanta, GA · 30346-1227

Is this the product you have?

  • Monaco Radiation Treatment Planning (RTP) System
Lot codes and dates
  • Software version 5.40
Amount recalled
14 devices

Where it was sold

Why it was recalled

If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.

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 Aug 19, 2024 · Data as of Sep 19, 6:55 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.