Device product
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Z-1009-2017
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 76028
- Status
- Terminated
- Classification
- Class II
- Quantity
- 279
- Official record key
device-enforcement:Z-1009-2017
Official wording
Reason: Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
Code information: Software Versions 5.00 and higher
Distribution pattern: Worldwide Distribution - US Nationwide in the state of CA, IN, KY, MA, NJ, NY, NC, PA, TX, WI, and the countries of Brazil, Canada, China, Croatia, Estonia, Germany, India, Japan, Netherlands, New Zealand, Norway, Poland, Serbia, South Africa, Spain, Russia, Turkey
Derived failure modes
-
Unknown
Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.