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U.S. Department of Health and Human Services

Class 2 Device Recall Monaco Radiation Treatment Planning (RTP) System

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 Class 2 Device Recall Monaco Radiation Treatment Planning (RTP) Systemsee related information
Date Initiated by FirmFebruary 08, 2019
Create DateFebruary 27, 2019
Recall Status1 Terminated 3 on August 19, 2024
Recall NumberZ-0965-2019
Recall Event ID 82072
510(K)NumberK183037 
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
ProductMonaco Radiation Treatment Planning (RTP) System
Code Information Software version 5.40
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information Contact
770-670-2422
Manufacturer Reason
for Recall		If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.
FDA Determined
Cause 2		Software design
ActionElekta notified customers on about 2/08/2019 via "URGENT IMPORTANT FIELD SAFETY NOTIFICATION." Instructions included to ensure the optimization model is set to "Reproduce Goal Dose" when creating a completion plan. Customers were also requested to post the recall notice in an accessible place for all users to see, advise the appropriate personnel working with the device of the recall, and to complete and return the Acknowledgement Form. The issue will be resolved in Monaco release 5.40.01.
Quantity in Commerce14 devices
DistributionDomestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MUJ
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