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Class 2 Device Recall Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. |
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Date Initiated by Firm |
January 13, 2011 |
Date Posted |
June 14, 2011 |
Recall Status1 |
Terminated 3 on April 03, 2014 |
Recall Number |
Z-2561-2011 |
Recall Event ID |
57760 |
510(K)Number |
K071938 K091179
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Product Classification |
System, Planning, Radiation Therapy Treatment - Product Code MUJ
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Product |
Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above.
The Monaco RTP system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed. |
Code Information |
Release 2.03.00 and above. |
Recalling Firm/ Manufacturer |
Computerized Medical Systems Inc 13723 Riverport Drive Suite 100 Maryland Heights MO 63043
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For Additional Information Contact |
Christopher Ivicevich 408-830-8023
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Manufacturer Reason for Recall |
Monaco: For VMAT plans, the measured dose of radiation delivered is lower than the software calculated dose by about 5% in Monaco Release 2.03.00 and 2.04.00.
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FDA Determined Cause 2 |
Software design |
Action |
Computerized Medical Systems, Inc. sent a "USER NOTICE" on January 13, 2011, to all affected users. This notice identified the product, the problem, and the action needed to be taken by the customer. A return postcard is included for the customer to confirm receipt of the user notification.
The firm intends for correction in the dose calulation engine to appear in the Monaco Release 3.00 in March 2011.
Any further questions please call (403) 830-8023. |
Quantity in Commerce |
94 |
Distribution |
Worldwide Distribution-- USA (nationwide) and countries of Austria, Australia, Belarus, Canada, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Singapore, Slovenia, South Korea, Spain, Switzerland, Taiwan, Thailand and 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 = COMPUTERIZED MEDICAL SYSTEMS, INC.
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