Class 2 Device Recall RayStation/RayPlan software system for radiation therapy

• Date Initiated by Firm: February 20, 2020
• Create Date: March 10, 2020
• Recall Status: Open, Classified
• Recall Number: Z-1465-2020
• Recall Event ID: 85065
• 510(K)Number: K190387
• Product Classification: System, planning, radiation therapy treatment - Product Code MUJ
• Product: RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system
• Code Information: UDI 07350002010204
• Recalling Firm/ Manufacturer: RAYSEARCH LABORATORIES AB; Sveavagen 9; Stockholm Sweden
• For Additional Information Contact: Edward Shepp; 877-7783849
• Manufacturer Reason for Recall: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
• FDA Determined Cause: Under Investigation by firm
• Action: An Urgent Field Safety Notice, Medical Device Correction notification letter dated 2/19/20 was emailed to the customer. ACTIONS TO BE TAKEN BY THE USER " Either do not use the RayTreat tabletop propagation functionality or make sure to always perform imaging and registration correction before each treatment session. " When using RayTreat in combination with the ProNova machine, do not use the acquired imaging positions in the preparation tab as the truth about where an image was actually taken. Please educate all users including the planning, Quality Assurance and plan delivery staff 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 notice by replying to the notification email. SOLUTION This issue will be resolved in the next version of RayStation, scheduled for market release in March 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. TRANSMISSION OF THIS NOTICE This notice needs to be passed on to all those who need to be aware within your organization. Please maintain awareness of this notice as long as any version of RayStation affected by this issue is in use to ensure effectiveness of the workaround.
• Quantity in Commerce: 1 system in the U.S.
• Distribution: The products were distributed to the following US states: TN
• 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