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Class 2 Device Recall Monaco |
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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
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Product Classification |
System,planning,radiation therapy treatment - Product Code MUJ
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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
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For Additional Information Contact |
Linda Wetsel 404-993-5886
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = MUJ and Original Applicant = IMPAC MEDICAL SYSTEMS, INC.
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