Reported Sep 4, 2019 · Terminated
Monaco Radiation Treatment Planning System (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 System (RTP) System
- Lot codes and dates
- Software Build5.50.00 & 5.51.00
- UDI GTIN
(01)00858164002244(10) 5.50.00(01)00858164002268(10) 5.51.00
- Amount recalled
- 49 units
Where it was sold
Why it was recalled
Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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