Class 2 Device Recall RayStation

• Date Initiated by Firm: October 08, 2020
• Create Date: November 20, 2020
• Recall Status: Terminated on March 30, 2023
• Recall Number: Z-0478-2021
• Recall Event ID: 86668
• 510(K)Number: K200569
• Product Classification: System, planning, radiation therapy treatment - Product Code MUJ
• Product: RayStation standalone software treatment planning system, 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 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.
• 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: If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI.
• FDA Determined Cause: Software design
• Action: On October 8, 2020, the firm emailed "Field Safety Notice, Medical Device Correction #66704" to affected customers. Customers were made aware of the product issue and asked to take the following actions: " Do not exclude the prescription ROI or POI when exporting from RayStation with the Exclude from export option. " If an RT Structure Set where it is not certain that all referenced bolus and prescription ROIs or POIs are present is imported to RayStation, make sure to check that any intended references to bolus and prescription are correct after import. " 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, scheduled for market release in November 2020 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation 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. For regulatory information, please contact quality@raysearchlabs.com
• Quantity in Commerce: 2768
• 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