Class 2 Device Recall Elekta Unity MRLinac, ImageGuided Radiation Therapy System

• Date Initiated by Firm: May 21, 2020
• Date Posted: June 08, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2297-2020
• Recall Event ID: 85600
• 510(K)Number: K192482
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
• Code Information: Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571. UDI Number 05060191071321. Anatomy (Protocol Name): Abdomen (btFFE Cor RealTime, btFFE Cor Sag RealTime, btFFE Cor Sag Tra RealTime, btFFE Fast Sag Cor RealTime, btFFE Sag RealTime); HeadNeck L (bFFE Cor RealTime, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); HeadNeck M (bFFE Cor RealTime, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); Pelvis L (bFFE Cor RealTime, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); Pelvis M (bFFE Cor RealTime, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); Thorax (btFFE Cor RealTime, btFFE Cor Sag RealTime, btFFE Cor Sag Tra RealTime, btFFE Sag RealTime, btFFE Sag RealTime)
• Recalling Firm/ Manufacturer: Elekta Limited; Linac House; Fleming Way; Crawley United Kingdom
• Manufacturer Reason for Recall: In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure.
• FDA Determined Cause: Device Design
• Action: Elekta notified customers of the recalls on about 05/21/2020 via "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" letter. Customers were informed that in TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure. Instructions included that although there is no method to correct the scaling issue for the affected protocols, the device can still be used under two options: 1. Without the use of Motion Monitoring and 2. compensation for intra-fraction motion can be done through the acquisition of a 3D Verification MRI, which is not impacted by the scaling issue. On 08/05/2020, Elekta issued an additional customer notification to provide additional details of the recall status and to clarify and provide a more generic message regarding the recall issue.
• Quantity in Commerce: 26 units
• Distribution: US distribution to IA, NY, PA, TX, WI. International distribution to Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Turkey, United Kingdom.
• 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 = IYE and Original Applicant = Elekta Limited