Elekta Inc Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy. 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. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Brand
Elekta Inc
Lot Codes / Batch Numbers
Software Build: 5.11.00, 5.11.01, 5.11.02, 5.11.03, UDI Numbers: (01)00858164002169(10)5.11.00, (01)00858164002169(10)5.11.01, (01)00858164002169(10)5.11.02, (01)00858164002169(10)5.11.03
Products Sold
Software Build: 5.11.00, 5.11.01, 5.11.02, 5.11.03; UDI Numbers: (01)00858164002169(10)5.11.00, (01)00858164002169(10)5.11.01, (01)00858164002169(10)5.11.02, (01)00858164002169(10)5.11.03
Elekta Inc is recalling Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam due to Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
Recommended Action
Per FDA guidance
Elekta notified consignees of the issue on 02/28/2023 via email. Consignees were instructed to contact Elekta Care Support if assistance is needed to identify affected patients, post the recall information in a place accessible to all users until the action is complete, and complete and return the Important Field Safety Notice Acknowledgement form. Additionally, the issue is corrected in Monaco releases 5.40 and above. If you are running a 5.11.xx version, please contact Elekta Care Support to upgrade to a newer software version.
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 noticePage updated: Jan 10, 2026