| Class 2 Device Recall Focal Radiation Treatment Planning System | |
Date Initiated by Firm | May 10, 2010 |
Date Posted | June 20, 2011 |
Recall Status1 |
Terminated 3 on April 02, 2014 |
Recall Number | Z-2592-2011 |
Recall Event ID |
58269 |
510(K)Number | K013112 |
Product Classification |
System, planning, radiation therapy treatment - Product Code MUJ
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Product | Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above
for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system. |
Code Information |
Focal Release 4.50.00 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 408-380-8023 |
Manufacturer Reason for Recall | Focal: for XiO plans calculated in relative dose mode, the Focal Plan Review application will display the DVH and maximum dose correctly. However, the isodose display is not scaled correctly. If the user evaluated the plan based only on the isodose display, they might misinterpret the actual dose delivered to the patient. |
FDA Determined Cause 2 | Software design |
Action | Elekta / Computerized Medical Systems Inc sent an undated Safety Notice to consignees beginning on May 21, 2010. The notice identified the product, the problem, and a workaround. |
Quantity in Commerce | 308 |
Distribution | Worldwide Distribution - USA (Nationwide including Puerto Rico)
Foreign distribution was made to Albania, Australia, Austria, Belgium, Canada, Chile, China, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Portugal, Russia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, and Turkmenistan. |
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
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