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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 July 12, 2012
Recall Status1 Terminated on April 01, 2014
Recall Number Z-2007-2012
Recall Event ID 62434
Premarket Notification
510(K) Number
K110730 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product Monaco Product Usage: Planning of radiation therapy
Code Information Version 3.10.00 - 3.20.00, inclusive
Recalling Firm/
Manufacturer
Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross, Georgia 30092-3011
For Additional Information Contact Thomas Valentine
770-670-2548
Manufacturer Reason
for Recall
Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
FDA Determined
Cause 2
DESIGN: Software Design
Action Elekta sent an Important Safety Notice to affected customers. The notice identified the affected product, problem, clinical impact and actions to be taken. The notice inform customers of how the issue will be resolved and instructions to follow when it is available.
Quantity in Commerce 38
Distribution US Nationwide Distribution - including the states of: CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI
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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