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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 May 30, 2016
Create Date October 13, 2016
Recall Status1 Terminated 3 on September 22, 2017
Recall Number Z-0079-2017
Recall Event ID 74750
510(K)Number K160093  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product Radiation Therapy Treatment Planning System, Model 5.0
Code Information 5.0.0.37, 5.0.1.11 and 5.0.2.35
Recalling Firm/
Manufacturer
RAYSEARCH LABORATORIES AB
Sveavaegen 9
Stockholm Sweden
Manufacturer Reason
for Recall
For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.
FDA Determined
Cause 2
Software design
Action On May 19th, 2016, RaySearch Laboratories distributed Field Safety Notice, Medical Device Correction notices and reply forms to their customers via email. Actions to be taken by the customer include: 1) Inspect all report templates that are intended to be used for plans with multiple beam sets. 2) Make sure that POI Dose statistics (Plan) is included immediately before ROI Dose statistics [Plan dose] in the Report content area. 3) Please educate planning staff and all users about this workaround. 4) Inspect your product and identify all installed units with the above software version number. Finally, complete and return the reply form via email to: freddie.cardel@raysearchlabs.com or by fax to: 888-501-7195 to confirm that you have read and understand the information. Customers with questions can contact David Hedfors via email: david.hedfors@raysearchlabs.com
Quantity in Commerce 491 units (187 domestically & 304 internationally)
Distribution AZ, CA, FL, MT, NC NY, TX, OH & 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)
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