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U.S. Department of Health and Human Services

Class 2 Device Recall Monaco Radiation Treatment Planning Workstation

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 Class 2 Recall
Monaco Radiation Treatment Planning Workstation
see related information
Date Posted June 15, 2011
Recall Status1 Terminated on April 02, 2014
Recall Number Z-2569-2011
Recall Event ID 57843
Premarket Notification
510(K) Numbers
K071938  K091179 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 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 Release 2.04 and higher
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: In XiO IMRT (Dynamic MLC Delivery) software, the radiation beam angle is set to zero. If different beam angles are selected via Monaco software, the beam angles will remain at zero.
FDA Determined
Cause 2
DESIGN: Software Design
Action Computerized Medical Systems, Inc. sent a User Notice to the affected consignees on October 27, 2010, explaining the reason for correction, the clinical impact, and the workaround method. (VERIFY USE NOTICE DATE) A return postcard was included for the customer to confirm receipt of the User Notice. The firm intends for this issue to be corrected in Monaco Release 3.00 in March 2011.
Quantity in Commerce 11
Distribution Worldwide Distribution - USA including CA, IL, MN, NM, OH, NY, TX, and WA and the Netherlands.
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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