Class 2 Device Recall Raystation

• Date Initiated by Firm: February 17, 2023
• Date Posted: March 22, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1281-2023
• Recall Event ID: 91867
• 510(K)Number: K190387
• Product Classification: System, planning, radiation therapy treatment - Product Code MUJ
• Product: Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12.0.3, 12.1.2, 12.0.4, 12.1.3, 13.0.0, 13.1.0. Software Version Numbers 9A, 9B, 10A, 10B, 11A, 11B and 12A including service packs
• Code Information: UDI-DI: 0735000201067920221007
• Recalling Firm/ Manufacturer: RAYSEARCH LABORATORIES AB; Eugeniavagen 18c; Stockholm Sweden
• Manufacturer Reason for Recall: It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not be correct in the exported RT plan. In the exported RT plan, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero, regardless of the selected collimator angle.
• FDA Determined Cause: Under Investigation by firm
• Action: A Field Safety Notice, Medical Device Correction letter dated 2/16/23 was sent to customers. Actions to be taken by the user " Be aware that an RT plan exported by using the VSIM Export button will always have the DICOM attribute Beam Limiting Device Angle (300A,0120) set to zero. " Be aware that an RT plan exported by using the VSIM Export button will always have the DICOM attribute Number of Wedges (300A,00D0) set to zero and no wedge information will be exported. " Be aware that an RT plan exported by using the VSIM Export button will never include the DICOM attribute Applicator Sequence (300A,0107) and no cone information will be exported. " Do not use or export Virtual Simulation plans with non-zero collimator angle, wedges or cones using the VSIM Export button. " Be aware that a plan imported as a Virtual Simulation plan may not contain all intended information and that some attributes affecting dose may be different from the original plan. " Always perform dose computation for imported Virtual Simulation plans before export. Do not use the VSIM Export for export of such plans. " 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. Solution This issue will be resolved in the next version of RayStation, scheduled for market release in June 2023 (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. Transmission of this Notice This notice needs to be passed on to all those who need to be aware within your organization. Maintain awareness of this notice as long as any affected version is in use.
• Quantity in Commerce: 10770 systems
• Distribution: US Nationwide
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MUJ and Original Applicant = RaySearch Laboratories AB (publ)