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U.S. Department of Health and Human Services

Class 2 Device Recall FOCAL Workstation

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 Class 2 Device Recall FOCAL Workstationsee related information
Date Initiated by FirmJanuary 19, 2009
Date PostedJune 20, 2011
Recall Status1 Terminated 3 on April 10, 2014
Recall NumberZ-2594-2011
Recall Event ID 58253
510(K)NumberK013112 
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
ProductFocal Radiation Treatment Planning System, Focal Release 4.40.00 and above. Product Usage: 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 4.40.00 and above
Recalling Firm/
Manufacturer		 Computerized Medical Systems Inc
13723 Riverport Drive
Suite 100
Maryland Heights MO 63043
For Additional Information ContactChristopher Ivicevich
408-380-8023
Manufacturer Reason
for Recall		Focal: the couch position can be moved between scans of the same CT study. When the images are imported into Focal, the software is not checking the DICOM Image Position (Patient) tag and therefore is not aligning the images sets if there are different couch positions indicated. A shift between image sets will exist of the same amount that the CT couch was moved.
FDA Determined
Cause 2		Software design
ActionElekta CMS Software sent an "ADVISORY NOTICE" dated January 19, 2009 to its affected customers. The notice identified the product, the problem, and the acton to be taken. Customers were informed that the workaround method available is to (use the image fusion feature already in Focal to relign the scans). The firm states that this issue is resolved in Focal version 4.62.00, which was released in March 2011. If you have any questions, please call 314-993-0003 or toll free 800-878-4267.
Quantity in Commerce31
DistributionWorldwide Distribution -- USA (nationwide) including states of: CA, CO, FL, IL, IN, KS, MO, NC, OH, OK, PA, TN, and WA. and countries of Australia, Austria, Canada, India, Netherlands, Portugal, Singapore, Spain, and United Kingdom.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MUJ
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