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U.S. Department of Health and Human Services

Class 2 Device Recall Monaco RTP System

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 Class 2 Recall
Monaco RTP System
see related information
Date Posted June 14, 2011
Recall Status1 Terminated on April 04, 2013
Recall Number Z-2560-2011
Recall Event ID 58229
Premarket Notification
510(K) Numbers
K071938  K091179 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product Monaco Radiation Treatment Planning System, Monaco Release 1.0.0 through 1.0.2. Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed.
Code Information XiO Release 1.0.0 through 1.0.2 All lot or serial numbers
Recalling Firm/
Manufacturer
Computerized Medical Systems Inc
13723 Riverport Drive
Suite 100
Maryland Heights, Missouri 63043
Consumer Instructions No consumer action necessary
For Additional Information Contact Christopher Ivicevich
408-380-8023
Manufacturer Reason
for Recall
Monaco: If the user selects Monte Carlo Photon as the Secondary Algorithm (to be used for final dose calculation through segments), and selects SKIP Forward button at any time during stage 2 optimization, the system may only use the pencil beam algorithm for final computation of dose even though Monte Carlo was selected. Other than specific output to the console window, there will be no other in
FDA Determined
Cause 2
DESIGN: Software Design
Action Computerized Medical Systems, Inc. sent a "MONACO CUSTOMER ADVISORY" letter dated June 2008 to all affected customers. The letter describes the product, problem, and the action to be taken. The customer was instructed to use caution when using the Skip Forward button in stage 2 according to written instructions provided in the letter. This defect exists in Monaco Release 1.0.0 through 1.0.2 and will be resolved as soon as possible. Note: The issue was resolved in Monaco Release 2.0.1 and above. Questions should be directed to the manufacturer's representative telephone number at 408-830-8023.
Quantity in Commerce 47
Distribution Worldwide Distribution-- USA (nationwide) including the states of IL, MI, MO, OR, SC, TX, VA, and Puerto Rico and the countries of Canada, China, Cyprus, Estonia, France, Germany, Greece, Italy, Japan, Netherlands, Philippines, Poland, Portugal, Slovenia, South Korea, Spain, and United Kingdom.
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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