Elekta, Inc. Monaco Radiation Treatment Planning System (RTP) System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Monaco Radiation Treatment Planning System (RTP) System
Brand
Elekta, Inc.
Lot Codes / Batch Numbers
Software Build: 5.50.00 & 5.51.00, UDI GTIN: (01)00858164002244(10) 5.50.00, (01)00858164002268(10) 5.51.00
Products Sold
Software Build: 5.50.00 & 5.51.00; UDI GTIN: (01)00858164002244(10) 5.50.00, (01)00858164002268(10) 5.51.00
Elekta, Inc. is recalling Monaco Radiation Treatment Planning System (RTP) System due to Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, OH
Page updated: Jan 10, 2026