Class 2 Device Recall RaySearch

• Date Initiated by Firm: June 29, 2018
• Create Date: July 19, 2018
• Recall Status: Terminated on July 16, 2020
• Recall Number: Z-2497-2018
• Recall Event ID: 80459
• 510(K)Number: K180379
• Product Classification: System, planning, radiation therapy treatment - Product Code MUJ
• Product: RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A); ; Product Usage:; RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
• Code Information: Software Versions 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10, 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 4.9.0.42 , 5.0.0.37 , 5.0.1.11 , 5.0.2.3 , 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 7.0.0.19 , 8.0.0.61
• Recalling Firm/ Manufacturer: RAYSEARCH LABORATORIES AB; Sveavagen 9; Stockholm Sweden
• Manufacturer Reason for Recall: If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the collimator is rotated. This could lead to potentially significant overdosage at delivery. The user must be aware of the issue to avoid incorrect dose calculations during treatment planning.
• FDA Determined Cause: Under Investigation by firm
• Action: On June 29, 2018, the firm issued an Urgent Field Safety Notice, Medical Device Correction #32484 to affected customers via email. The firm notified customers of the issue with the affected models: If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the collimator is rotated. The user was instructed to do the following: 1. Inspect the beam model for all LINACs with jaw movement per beam, x-jaws and where the MLC is not above both jaws (i.e., Varian style LINACs) that allow DMLC planning. 2. If either the x- or y width of the primary source is below 0.01 cm or if they differ with more than a factor 2, do not use this beam model for DMLC. Contact RaySearch support for further assistance in adjusting the beam model and identifying potentially affected patients. 3. Please educate physics staff about this issue. 4. Inspect your product and identify all installed units with the above software version number(s), then confirm that you have read and understood this notice by replying to the notification email. The firm plans to resolve the issue in the next version of RayStation/RayPlan, scheduled for market release in 2018 (subject to market clearance in some markets).
• Quantity in Commerce: 746
• Distribution: US Nationwide Distribution to accounts in AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI.
• 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 (publ)