Class 2 Device Recall RayStation

• Date Initiated by Firm: March 28, 2018
• Create Date: June 26, 2018
• Recall Status: Terminated on May 27, 2020
• Recall Number: Z-2290-2018
• Recall Event ID: 80252
• 510(K)Number: K171536
• Product Classification: System, planning, radiation therapy treatment - Product Code MUJ
• Product: RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: 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: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 and 7.0.0.19
• FEI Number: 3007774465
• Recalling Firm/ Manufacturer: RAYSEARCH LABORATORIES AB; Sveavagen 9; Stockholm Sweden
• Manufacturer Reason for Recall: The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.
• FDA Determined Cause: Software design
• Action: On March 28, 2018, the firm issued a Field Safety Notice, Medical Device Correction letter to its affected customers. The firm instructed users to take the following actions: -Do not use MLC only collimated to set output factor corrections (OFCs) in beam modeling of Elekta Synergy machines with MLCi/MLCi2 or any other machine with the MLC closer to the source than both the x- and y-jaws. Always use Jaws and MLC collimated. -Be aware that there is an error in the field measure calculation for machines with the MLC closer to the source than both the x- and y-jaws, and for machines with fixed jaws. Make sure to perform patient-specific QA before treatment delivery for treatment plans with fields where: 1) closed MLC leaves are positioned inside the jaw field and 2) the minimum static/dynamic tip gap is larger than 0.001 cm. Please educate planning staff and all users about this workaround. Inspect your product and identify all installed units with the above software version number(s), then confirm you have read and understood this information by replying to the notification email. This issue will be resolved in the next version of RayStation/RayPlan, scheduled for market release in June 2018 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation/RayPlan affected by this Field Safety Notice, all users must maintain awareness of this Field Safety Notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use.
• Quantity in Commerce: 728
• Distribution: US Nationwide Distribution in the states of AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, ID, IL, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, VT, WA, 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