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U.S. Department of Health and Human Services

Class 2 Device Recall Focal SIM

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 Class 2 Device Recall Focal SIMsee related information
Date Initiated by FirmJune 21, 2012
Date PostedJuly 12, 2012
Recall Status1 Terminated 3 on April 01, 2014
Recall NumberZ-2002-2012
Recall Event ID 62433
510(K)NumberK013112 
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
ProductFocal SIM Planning of radiation therapy
Code Information Version 4.64.00 - 4.700, inclusive
Recalling Firm/
Manufacturer		 Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross GA 30092-3011
For Additional Information ContactThomas Valentine
770-670-2548
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		Software design
ActionIMPAC 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 Commerce38 units
DistributionNationwide Distribution including CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI.
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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