Class 2 Device Recall RayAutoplan, aka tRayAutoplan, commercial name (TomoTherapy) SharePlan

• Date Initiated by Firm: May 30, 2011
• Date Posted: September 14, 2012
• Recall Status: Terminated on November 16, 2012
• Recall Number: Z-2378-2012
• Recall Event ID: 63110
• 510(K)Number: K083264
• Product Classification: System,planning,radiation therapy treatment - Product Code MUJ
• Product: The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1 . To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10 .; ; 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: SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10).
• Recalling Firm/ Manufacturer: RAYSEARCH LABORATORIES AB; Sveavaegen 9; Stockholm Sweden
• Manufacturer Reason for Recall: This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in the user manual. None of these behaviors have 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 delivere
• FDA Determined Cause: Labeling False and Misleading
• Action: RaySearch Laboratories sent an Urgent Field Safety Notice Medical Device Correction dated May 30, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consigness were instructed to completely avoid affecting the erroneous behaviour, verify in TomoTherapy Hi-Art that the plans sent to TomoTherapy SharePlan 1.1 only have one single fraction group with a single fraction size,used for all fractions, and do not attempt to import treatment plans having more than one fraction size into the product. To completed avoid affecting the erroneous behaviour the user can either offset the measured curves before importing them into beam commissioning or add the depth offset tothe calibration depth. For further information consigness should contact RaySearch Laboratories AB Quality and Regulatory Affairs at +46 722 366 110 or the Tomo Therapy support at support@tomotherapy.com. North America 1 866 368 4807 Belgium 0800 38783 France 0805 631 565 Germany 0800 000 +541 Italy 800-986 399 Netherlands 0800 0201364 Spain 800 3000049 Switzerland 0800 001927 UK 0868 238 6035 China/Northern 10 800 712 1701 China/Southern 10800 120 1701 Hong Kong 800 967912 Japan 0044 22 132374 Singapore 800 1204683 South Korea 0079 81 4800 7204 All other locations + 1 608 824 2900 or +32 2 40 44 44
• Quantity in Commerce: 15 units
• Distribution: Worldwide Distribution - USA including CA, KY, MI, NY, OK, and OR. Internationally to Canada, Belgium, United Kingdom, Australia, France, Germany, and Poland.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = MUJ and Original Applicant = RAYSEARCH LABORATORIES AB