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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 February 11, 2013
Date Posting Updated February 20, 2013
Recall Status1 Terminated 3 on January 21, 2014
Recall Number Z-0841-2013
Recall Event ID 64328
510(K)Number K110730  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product Monaco RTP System.

Radiation treatment planning.
Code Information Versions 3.20.00 and 3.20.01
Recalling Firm/
Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Chris Ivicevich
Manufacturer Reason
for Recall
The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Elekta provided customers with an "Important Safety Notice - Dose Display Not Matching Beam Geometry - Monaco RFC 35748". The notice identified the product, problem, and actions to be taken by the customers. Contact the form at 800-878-4267 for questions relating to this notice.
Quantity in Commerce 13
Distribution Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, 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.