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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 June 01, 2022
Create Date July 19, 2022
Recall Status1 Terminated 3 on October 04, 2023
Recall Number Z-1403-2022
Recall Event ID 90498
510(K)Number K200569  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product RayStation 9B SP1. For radiation treatment planning.
Code Information UDI-DI: 0735000201029720200310 Build number 9.2.0.483
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Sveavagen 9
Stockholm Sweden
Manufacturer Reason
for Recall		 An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.
FDA Determined
Cause 2		 Software change control
Action The firm contacted all customers via email on June 1, 2022. Customers were provided with a list of workflows where safety related information may not be propagated. Customers were instructed to be aware that treatment course information in RayCare may not always be up to date. Customers should verify critical information in RayStation or RayTreat before treatment course information in RayCare is used for critical decisions. Customers were asked to identify all installed units with the affected software version numbers. The issue will be resolved in mandatory software updates for RayStation, scheduled for market release in June 2022.
Quantity in Commerce 1
Distribution Worldwide distribution - US Nationwide distribution in the state of TN and the countries of Belgium and Switzerland.
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)
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