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U.S. Department of Health and Human Services

Class 2 Device Recall Radiation Treatment Planning System

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  Class 2 Device Recall Radiation Treatment Planning System see related information
Date Initiated by Firm November 22, 2019
Create Date December 12, 2019
Recall Status1 Open3, Classified
Recall Number Z-0670-2020
Recall Event ID 84330
510(K)Number K183037  K190178  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product Monaco Radiation Treatment Planning System (RTP) System
Code Information 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   
Recalling Firm/
Manufacturer		 Elekta Inc
1450 Beale St Ste 205
Saint Charles MO 63303
For Additional Information Contact
800-878-4267
Manufacturer Reason
for Recall		 Monaco is using the incorrect energy when optimizing and calculating dose.
FDA Determined
Cause 2		 Software Design Change
Action 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.
Quantity in Commerce 76 (7 US, 69 OUS)
Distribution IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = Elekta, Inc
510(K)s with Product Code = MUJ and Original Applicant = Elekta, Inc.
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