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 Builds: 5.40.00, 5.50.00 and 5.51.00. UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002244(10) 5.50.00, and (01)00858164002268(10) 5.51.00
Products Sold
Software Builds: 5.40.00, 5.50.00 and 5.51.00. UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002244(10) 5.50.00, and (01)00858164002268(10) 5.51.00
Elekta Inc is recalling Monaco Radiation Treatment Planning System (RTP) System due to Monaco is using the incorrect energy when optimizing and calculating dose.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Monaco is using the incorrect energy when optimizing and calculating dose.
Recommended Action
Per FDA guidance
An Important Field Safety Notification letter is being emailed to affected customers beginning 11/22/2019. The letter identifies affected product, provides a description of the problem, and recommends user not use multiple energies within the same plan until a software fix has been applied to the device. A response form was asked to be returned. Affected customers are advised to contact local Elekta service teams for questions.
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, IA, NY, OH, TX, WI
Page updated: Jan 10, 2026