Class 2 Device Recall

• Date Initiated by Firm: May 22, 2013
• Date Posted: September 25, 2013
• Recall Status: Terminated 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/ 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: Patient needs to be positioned as indicated by the treatment plan.
• FDA Determined Cause: 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.