Class 2 Device Recall RayStation

• Date Initiated by Firm: November 11, 2020
• Create Date: December 15, 2020
• Recall Status: Terminated on May 09, 2023
• Recall Number: Z-0589-2021
• Recall Event ID: 86832
• 510(K)Number: K200569
• Product Classification: System, planning, radiation therapy treatment - Product Code MUJ
• Product: RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0)
• Code Information: Software version numbers: 4.0.0.14 , 4.0.3.4 , 4.5.1.14 , 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 4.7.6.7 , 4.9.0.42 ,; 5.0.1.11 , 5.0.2.35 , 5.0.3.17 , 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154
• Recalling Firm/ Manufacturer: RAYSEARCH LABORATORIES AB; Sveavagen 9; Stockholm Sweden
• Manufacturer Reason for Recall: Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid; and 2) For RayStation and RayPlan 9B and 10A, 6D couch angles may be incorrect.
• FDA Determined Cause: Software design
• Action: On November 11, 2020, the firm issued Field Safety Notices to affected customers via email. Customers were informed of the affected versions and the product issue. ACTIONS TO BE TAKEN BY THE USER: " Always verify in the RayStation/RayPlan GUI that all relevant regions of interest (ROIs) are within the dose grid. " If using the treatment plan report for evaluation of clinical goal results, verify the percentage outside the dose grid (% outside grid) for each ROI in the RayStation/RayPlan GUI. " In the treatment plan report, be aware that the Couch pitch angle and Couch roll angle values for setup beams may be incorrect. " Use exported DICOM plans, not the treatment plan report, for transferring treatment parameters to the delivery system. " 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). " Confirm you have read and understood this notice by replying to the notification email. This issue will be resolved in the next version of RayStation and RayPlan, scheduled for market release in November 2020 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation and RayPlan affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use.
• Quantity in Commerce: 124
• Distribution: US Nationwide distribution.
• 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)