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U.S. Department of Health and Human Services

Class 2 Device Recall SharePlan 1.1

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 Class 2 Recall
SharePlan 1.1
see related information
Date Posted September 24, 2012
Recall Status1 Terminated on January 25, 2013
Recall Number Z-2444-2012
Recall Event ID 63186
Premarket Notification
510(K) Number
K083264 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists.
Code Information version 1.2.1 (build number 1.3.1.10).
Recalling Firm/
Manufacturer
RAYSEARCH LABORATORIES AB
Sveavaegen 9
Stockholm
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment. The behavior appears, when importing RFA-files (.asc)
FDA Determined
Cause 2
DESIGN: Software Design
Action RaySearch Laboratories sent an Urgent Field Safety Notice Medical Device Correction letter dated October 10, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. To completely avoid effects of the erroneous behaviour, RFA-file has to be modified to have the crossline profiles sgtored in the X column of the file and the inline profiles in the Y column. Upon request, RaySearch Laboratories will provide help to the customers by transferring the RFA-files to the correct format through a scrip. Customers were instructed to pass on the notice to all those who need to be aware within their organization and to maintain awareness on this notice until the new labeling version has been received to ensure effectiveness of the corrective action. For questions regarding this recall call +46 8 54 50 61 42.
Quantity in Commerce 20 units
Distribution Worldwide Distribution - USA including CA, KY, MI, NY, OK, OR, SD, and WI. Internationalyl to Canada, Sweden, France, Germany, Australia, Poland, Belgium, and United Kingdom.
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 = RAYSEARCH LABORATORIES AB
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