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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 22, 2013
Date Posting Updated September 25, 2013
Recall Status1 Terminated 3 on December 23, 2013
Recall Number Z-2277-2013
Recall Event ID 65998
510(K)Number K110730  
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product Monaco RTP System Radiation Therapy Treatment Planning System.

Radiation treatment planning.
Code Information All versions of Monaco
Recalling Firm/
Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Linda Wetsel
Manufacturer Reason
for Recall
Patient needs to be positioned as indicated by the treatment plan.
FDA Determined
Cause 2
Labeling design
Action Computerized Medical Systems issued an Important Safety Notice dated May 22, 2013 to all affected customers. This letter idenitfies the problems the products and the actions needed to be takem by the custom.
Quantity in Commerce 72
Distribution Distributed in Puerto Rico and the states of AK, AZ, CA, CO, CT, FL, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, and WA.
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.