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U.S. Department of Health and Human Services

Class 2 Device Recall Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above.

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  Class 2 Device Recall Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. see related information
Date Initiated by Firm January 13, 2011
Date Posted June 14, 2011
Recall Status1 Terminated 3 on April 03, 2014
Recall Number Z-2561-2011
Recall Event ID 57760
510(K)Number K071938  K091179  
Product Classification System, Planning, Radiation Therapy Treatment - Product Code MUJ
Product Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above.

The Monaco RTP system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed.
Code Information Release 2.03.00 and above.
Recalling Firm/
Manufacturer		 Computerized Medical Systems Inc
13723 Riverport Drive
Suite 100
Maryland Heights MO 63043
For Additional Information Contact Christopher Ivicevich
408-830-8023
Manufacturer Reason
for Recall		 Monaco: For VMAT plans, the measured dose of radiation delivered is lower than the software calculated dose by about 5% in Monaco Release 2.03.00 and 2.04.00.
FDA Determined
Cause 2		 Software design
Action Computerized Medical Systems, Inc. sent a "USER NOTICE" on January 13, 2011, to all affected users. This notice identified the product, the problem, and the action needed to be taken by the customer. A return postcard is included for the customer to confirm receipt of the user notification. The firm intends for correction in the dose calulation engine to appear in the Monaco Release 3.00 in March 2011. Any further questions please call (403) 830-8023.
Quantity in Commerce 94
Distribution Worldwide Distribution-- USA (nationwide) and countries of Austria, Australia, Belarus, Canada, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Singapore, Slovenia, South Korea, Spain, Switzerland, Taiwan, Thailand and UK.
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.
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