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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 System see related information
Date Initiated by Firm May 31, 2010
Date Posted June 14, 2011
Recall Status1 Terminated 3 on April 10, 2014
Recall Number Z-2564-2011
Recall Event ID 58258
510(K)Number K071938  K091179  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above

Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed.
Code Information Monaco Release 2.0.1 and above
Recalling Firm/
Computerized Medical Systems Inc
13723 Riverport Drive
Suite 100
Maryland Heights MO 63043
For Additional Information Contact Christopher Ivicevich
Manufacturer Reason
for Recall
Monaco: due to a software defect, the Radiological Depth (cm) and SSD to DRP (cm) parameters are reported incorrectly on the Beam Summary Report. This occurs for all Monaco IMRT plans.
FDA Determined
Cause 2
Software design
Action Computerized Medical System sent a "USER NOTICE" letter dated June 24, 2010, to all affected users. This notice identified the product, the problem, and the actions to be taken. There is no current workaround. All customers will be mailed a postcard to be returned as proof of receipt and understanding of the notification. Consignees will be contact via telephone or e-mail after June 30, 2010 if the postcard is not returned This notice is to be distributed to any and all users of CMS software at your organization who are potentially affected. The notice states the issue will be resolved in Monaco Release 2.04, but no date for this release was given. For further questions, please call (403) 830-8023
Quantity in Commerce 62
Distribution Worldwide Distribution -- USA (nationwide) and the countries of Australia, Austria, Belgium, China, Finland, France, Germany, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, Switzerland, Taiwan, Thailand and 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = COMPUTERIZED MEDICAL SYSTEMS, INC.