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U.S. Department of Health and Human Services

Class 2 Device Recall Monaco Radiation Treatment Planning System

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 Class 2 Device Recall Monaco Radiation Treatment Planning Systemsee related information
Date Initiated by FirmOctober 16, 2015
Date PostedOctober 30, 2015
Recall Status1 Terminated 3 on April 04, 2017
Recall NumberZ-0181-2016
Recall Event ID 72424
510(K)NumberK151233 
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
ProductMonaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Code Information Software Version 5.10.01
FEI Number 1037831
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information ContactLinda Wetsel
770-300-9725
Manufacturer Reason
for Recall		Unintended update of Dose and MU and Incorrect Assignment of Bolus.
FDA Determined
Cause 2		Other
ActionElekta sent Important Field Safety Notice 382-01-MON-003 to all customers on 10/16/2015. The notice informs users of the specific product and version numbers affected by both issues. The affected devices for both issues are those running Monaco 5.10.01. Customers are instructed to complete and return acknowledgement form. Solution/fix has been released in Monaco patch 5.10.02 and all affected users will be made aware of its availability by the end of October 2015.
Quantity in Commerce154
DistributionCA, IN, MI,MO, TX, WI, Australia, Canada, Germany,m Greece, India, Netherlands, New Zealand, Turkey and United Kingdom
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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