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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 September 15, 2015
Date Posted October 07, 2015
Recall Status1 Terminated 3 on April 04, 2017
Recall Number Z-0112-2016
Recall Event ID 72221
510(K)Number K151233  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product Monaco Radiation Treatment Planning System.

Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Code Information Software Version 5.10.00
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		 Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.
FDA Determined
Cause 2		 Device Design
Action The firm issued an URGENT IMPORTANT FIELD SAFETY NOTICE on 09/15/2015. The letter identified the affected device, as well as the reason for the recall, and clinical impact. Customers were informed that both issues would be resolved in Monaco Patch Release 5.10.01. The attached acknowledgement form should be completed, signed, and returned to a local Elekta Office or representative within 30 days. Questions regarding the notice should be directed to a local Elekta office.
Quantity in Commerce 154 units
Distribution Worldwide Distribution -- US, including the states of CA, IN, MI, MO, TX and WI; and, the countries of Australia, Canada, Germany, Greece, India, Netherlands, New Zealand, Turkey, and the UK.
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 = IMPAC MEDICAL SYSTEMS, INC.
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