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U.S. Department of Health and Human Services

Class 2 Device Recall Monaco

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  Class 2 Device Recall Monaco see related information
Date Initiated by Firm June 21, 2012
Date Posted July 12, 2012
Recall Status1 Terminated 3 on April 01, 2014
Recall Number Z-2007-2012
Recall Event ID 62434
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 GA 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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = COMPUTERIZED MEDICAL SYSTEMS, INC.
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