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U.S. Department of Health and Human Services

Class 2 Device Recall RayStation (Treatment Planning System)

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  Class 2 Device Recall RayStation (Treatment Planning System) see related information
Date Initiated by Firm April 21, 2021
Create Date June 09, 2021
Recall Status1 Open3, Classified
Recall Number Z-1838-2021
Recall Event ID 87977
510(K)Number K200569  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product RayStation (Treatment Planning System)
Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 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 , 10.0.1.52 or 10.1.0.613 .
Code Information Software version: RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 2 including some service packs.
Recalling Firm/
Manufacturer
RAYSEARCH LABORATORIES AB
Sveavagen 9
Stockholm Sweden
Manufacturer Reason
for Recall
Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. It also describes an issue with contouring when the spacing between slices is d 1 mm, present in RayStation/RayPlan versions from 6 up to 10A.
FDA Determined
Cause 2
Under Investigation by firm
Action On May 6, 2021, Raysearch issued an Urgent Medical Device Correction notice to customers via letter notifying them an issue was found with the voxelwise worst clinical goals in the Robust evaluation module for specified software versions of RayStation. Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. Actions to be taken by the user Voxelwise worst clinical goal in Robust evaluation - The user is advised to be careful when editing clinical goals in the Robust evaluation module and when evaluating the clinical goals for the voxelwise worst distributions. If a clinical goal needs to be edited, make sure to toggle between the Scenario view and Voxelwise min and max views to trigger an update. Contouring issue - The user is advised to always examine ROI geometries in the transversal view and in the reconstructed sagittal, coronal and 3D views to verify that they have the desired size and shape. - To avoid displaying a mix of manually drawn and reconstructed contours in the same 2D view, the user can explicitly convert the ROI geometry to voxel- or mesh representation by using the keep component tool or the deformation tool. This way all rendered contours will be reconstructed and also be identical to what will be exported. All - Educate planning staff and all users about these issues and the workarounds. - 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 The voxelwise worst issue will be resolved in the next version of RayStation, scheduled for market release in May 2021 (subject to market clearance in some markets). The contouring issue was resolved in RayStation 10B. If customers wish to continue using versions of RayStation affected by this notice, all users must maintain awareness of this notice. Alternatively, customers ca
Quantity in Commerce Domestic: 13,722 systems
Distribution Worldwide distribution - US Nationwide distribution in the states of AK, AL, AZ, CA, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, Colombia, Czech Republic, Denmark, Egypt, Estonia, France, French Polynesia, Germany, Hong Kong, China, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK,
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)
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