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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 Recall
Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above.
see related information
Date Posted June 14, 2011
Recall Status1 Terminated on April 03, 2014
Recall Number Z-2561-2011
Recall Event ID 57760
Premarket Notification
510(K) Number
K071938 
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, Missouri 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = COMPUTERIZED MEDICAL SYSTEMS, INC.
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