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U.S. Department of Health and Human Services

Class 2 Device Recall RayStation

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  Class 2 Device Recall RayStation see related information
Date Initiated by Firm January 22, 2021
Date Posted June 29, 2023
Recall Status1 Terminated 3 on July 03, 2023
Recall Number Z-2039-2023
Recall Event ID 92441
510(K)Number K200569  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1.
Code Information UDI-DI: 07350002010129 UDI-DI: 07350002010204 UDI-DI: 07350002010235 UDI-DI: 07350002010174 UDI-DI: 07350002010266 UDI-DI: 07350002010297 UDI-DI: 07350002010303 UDI-DI: 07350002010365 UDI-DI: 07350002010310
Recalling Firm/
RaySearch America Inc
350 5th Ave Ste 5000
The Empire State Building
New York NY 10118-0110
Manufacturer Reason
for Recall
A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose statistics for an incorrectly created ROI are used to determine if a plan is acceptable for treatment, this could potentially lead to an inappropriate plan being approved. The error could lead to a more conservative or more liberal plan than intended.
FDA Determined
Cause 2
Software design
Action Field Safety Notice 73474 was emailed January 22, 2021 to affected customers. The notice identifies affected RayStation models: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B running software versions RS 8.1, 9.0, 9.1, 9.2, 10.0, 10.1. Users are instructed not to use Create wall, Expand/Contract, or ROI algebra functions directly on ROIs created by the DL segmentation. Instead, convert the ROIs to contour or mesh representation before using the affected functions. Users are to confirm they read and understood the notice by replying to the email. Error fixed in RS 10B Service Pack 1 and corrected in the next version of RayStation.
Quantity in Commerce 5 systems
Distribution US: AZ, CA, GA & WA
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 and Original Applicant = RaySearch Laboratories AB (publ)