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U.S. Department of Health and Human Services

Class 2 Device Recall Focal SIM

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 Class 2 Recall
Focal SIM
see related information
Date Posted July 12, 2012
Recall Status1 Terminated on April 01, 2014
Recall Number Z-2002-2012
Recall Event ID 62433
Premarket Notification
510(K) Number
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product Focal SIM Planning of radiation therapy
Code Information Version 4.64.00 - 4.700, inclusive
Recalling Firm/
Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross, Georgia 30092-3011
For Additional Information Contact Thomas Valentine
Manufacturer Reason
for Recall
Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
FDA Determined
Cause 2
DESIGN: Software Design
Action IMPAC Medical Systems, Inc. sent an Important Safety Notice LINFFM0001/1.0 on June 21, 2012, to consignees on concerning a patch to the software. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to not use the DICOM coordinates option for Reports when printing the Setup Reference Diaglog. Customers were instructed go to www.elekta.com, select the SupportPlus Login at the tope of the page, enter their portal, select Downloads/Updates to download the latest patches. For questions regarding this recall call 770-670-2548.
Quantity in Commerce 38 units
Distribution Nationwide Distribution including CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = COMPUTERIZED MEDICAL SYSTEMS, INC.