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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 Device Recall Monaco RTP System see related information
Date Initiated by Firm July 02, 2013
Date Posted September 25, 2013
Recall Status1 Terminated 3 on May 08, 2014
Recall Number Z-2276-2013
Recall Event ID 65996
510(K)Number K110730  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product Monaco RTP System

Radiation treatment planning
Code Information Versions 3.10.00 and later
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Linda Wetsel
404-993-5886
Manufacturer Reason
for Recall		 Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.
FDA Determined
Cause 2		 Device Design
Action Monaco 3.3 upgrades have been temporarily halted and Important Safety Notice (LINMON0007) has been issued to effected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that couch files are checked for releases 3.20.00 and 3.30.00 to verify that the correct relative electron density values are being used in the dose calculation. If customers have edited the sample couch files, and previously upgraded to Monaco 3.20.00 or 3.30.00, their couch files have already been overwritten. Open the couch files, make the necessary updates to the couch parameters, and use the "Save As Treatment Couch" option to save the modified sample couch files to a new, unique name. Please note that the couch files can also be edited in Focal and then the patients opened in Monaco. Comparable Focal releases would be Focal4.64.00(Monaco 3.10.00), Focal4.70.00(Monaco 3.20.00) and Focal4.80.00 (Monaco 3.30.00). For questions regarding this recall call 404-993-5886.
Quantity in Commerce 45
Distribution Nationwide Distribution including AK, CA, CO, CT, FL, IL, IN, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, WA and Puerto Rico.
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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