Monaco Radiation Treatment Planning (RTP) System
- Company
- Elekta, Inc.
- Recall Initiated
- February 8, 2019
- Terminated
- August 19, 2024
- Recall Number
- Z-0965-2019
- Quantity
- 14 devices
- Firm Location
- Atlanta, GA
Reason for Recall
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.
Distribution
Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.
Lot / Code Info
Software version 5.40
Root Cause
Software design
Action Taken
Elekta notified customers on about 2/08/2019 via "URGENT IMPORTANT FIELD SAFETY NOTIFICATION." Instructions included to ensure the optimization model is set to "Reproduce Goal Dose" when creating a completion plan. Customers were also requested to post the recall notice in an accessible place for all users to see, advise the appropriate personnel working with the device of the recall, and to complete and return the Acknowledgement Form. The issue will be resolved in Monaco release 5.40.01.