Monaco Radiation Treatment Planning System (RTP) System
- Company
- Elekta, Inc.
- Recall Initiated
- August 23, 2019
- Terminated
- June 28, 2024
- Recall Number
- Z-2409-2019
- Quantity
- 49 units
- Firm Location
- Atlanta, GA
Reason for Recall
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.
Distribution
Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden.
Lot / Code Info
Software Build: 5.50.00 & 5.51.00; UDI GTIN: (01)00858164002244(10) 5.50.00, (01)00858164002268(10) 5.51.00
Root Cause
Device Design
Action Taken
Elekta Inc. notified customers on about 08/23/2019 via "IMPORTANT FIELD SAFETY NOTIFICATION" letter. The letter informed customers that the Monaco is displaying some incorrect shift information on the Scan and Setup Reference Report and is DICOM exporting incorrect shift information. Instructions included that all shifts should be verified before treatment, that a software fix is planned. Customer were also instructed to post the notice in a place accessible to all users, advise personnel working with the device of the issue, and to complete and return the Acknowledgement Form provided.