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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