Elekta Inc Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Brand
Elekta Inc
Lot Codes / Batch Numbers
Software Builds: 5.40.00, 5.40.01, 5.40.02
Products Sold
Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10 UDI: (01)00858164002190(10) 5.40.00 (01)00858164002190(10) 5.40.01 (01)00858164002190(10) 5.40.02 (01)00858164002268(10) 5.51.10
Elekta Inc is recalling Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 due to If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.
Recommended Action
Per FDA guidance
Elekta will send an Important Field Safety Notice 382-01-MON-019 to all affected customers beginning August 10, 2021. The notice informs users of the specific product and version numbers affected by the issue, and any workaround that can be used to avoid the issue. A copy of the Important Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. Customers are asked to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta representative as soon as possible, but no later than 30 days after receipt. This issue is expected to be addressed in a future Monaco release, tentatively scheduled for the end of June 2022.
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, NJ, NY, PA, TN, TX, WI
Page updated: Jan 10, 2026