| Class 2 Device Recall Focal Radiation Treatment Planning System, |  |
Date Initiated by Firm | March 31, 2008 |
Date Posted | June 15, 2011 |
Recall Status1 |
Terminated 3 on April 09, 2014 |
Recall Number | Z-2572-2011 |
Recall Event ID |
58233 |
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 4.3.1 through 4.34.02.
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 4.3.1 through 4.34.02 |
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: In absolute dose mode a beam with a port may be calculated with open normalization, with the result that the displayed dose reflects open normalization while the monitor units and QA plan reflect blocked normalization. This is particularly important when these beams also include compensators. The problem is detectable by looking at the delivered dose to the weight point in the patient as |
FDA Determined Cause 2 | Software design |
Action | Computerized Medical Systems Inc sent a "CUSTOMER ADVISORY" letter dated March 2008 to all affected customers. The letter describes the product, the problem and the actions to be taken. The firm provided a workaround for customers that states "Alternatively the plan can be imported directly into XIO". A copy of the Advisory was shipped with software within the affected range to those requesting a software upgrade.
The issue was resolved in Focal Release 4.40.00 introduced in June 2008.
The firm will send out a User Notice to all sites still running affected software to remind them that the issue resolution is available.
For further questions, please call (403) 830-8023. |
Quantity in Commerce | 307 |
Distribution | Worldwide Distribution -- USA (nationwide) and the countries of Albania, Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, India, Italy, Japan, Netherlands, Peru, Portugal, Qatar, Romania, Russia, Serbia, South Africa, South Korea, Spain, Thailand, Turkey, United Kingdom, Uruguay, and Venezuela. |
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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