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U.S. Department of Health and Human Services

Class 2 Device Recall Monaco

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 Class 2 Recall
Monaco
see related information
Date Posted April 03, 2012
Recall Status1 Terminated on April 01, 2014
Recall Number Z-1365-2012
Recall Event ID 61392
Premarket Notification
510(K) Number
K110730 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product Monaco Radiation Treatment Planning System, Version 3.10.00. Planning of radiation therapy.
Code Information Version 3.10.00
Recalling Firm/
Manufacturer
Computerized Medical Systems Inc
13723 Riverport Dr Ste 100
Maryland Heights, Missouri 63043-4819
For Additional Information Contact Christopher Ivicevich
408-380-8023
Manufacturer Reason
for Recall
An unnecessary dose refresh can occur in certain situations which causes inconsistencies in the Beam Doses and the Total Dose.
FDA Determined
Cause 2
DESIGN: Software Design
Action An "IMPORTANT SAFETY NOTICE" was issued between 3/5-9/12 via e-mail, FAX, or traditional mail. The Notice described the correct functioning of the system, the problem, when and why the issue occurs, the clinical impact, and the workaround. Patch 3.10.01 is now available. Customers can download their patch at the link provided in the Notice. The Notice also provided a list of offices where customers can contact if they have questions or further support is needed.
Quantity in Commerce 44
Distribution Worldwide Distribution -- USA, including the states of OH, IN, WI, CA, FL, IL, LA, NJ, MA, NC, and MO and the countries of Canada, Australia, Belgium, China, France, Germany, Japan, The Netherlands, New Zealand, Portugal, Switzerland, Taiwan, and the 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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