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U.S. Department of Health and Human Services

Class 2 Device Recall RayStation 5

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  Class 2 Device Recall RayStation 5 see related information
Date Initiated by Firm October 11, 2016
Create Date December 07, 2016
Recall Status1 Terminated 3 on June 11, 2019
Recall Number Z-0720-2017
Recall Event ID 75633
510(K)Number K160093  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product Radiation Therapy Treatment Planning System

Product Usage:
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
Code Information Build No: "5.0.0.37, 5.0.1.11 or 5.0.2.35. Only 5.0.2.35 was distributed in the U.S.
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Sveavaegen 9
Stockholm Sweden
Manufacturer Reason
for Recall		 An error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in RayStation 5. If a CT image set with the same Frame of Reference as the displayed auxiliary CT set exists in another case, the dose display may be incorrect. When the error occurs, the display of dose in patient views, including the maximum dose position, the dynamic isodose lines and the dose grid may be incorrect. The dose value normally displayed in the upper left corner when pointing in the 2D view may be incorrect or missing.
FDA Determined
Cause 2		 Software design
Action On October 11, 2016 RaySearch Laboratories distributed a Field Safety Notice, Medical Device Correction #13529 to customers via email. Customers were instructed to take caution when a patient has multiple cases. The following may be incorrect if there are image sets that shre the same Frame of Reference residing in different cases: *Display of evaluation dose computed on another CT image set and *Dose tracking fraction dose and deformed dose. Until a corrected version has been installed, all affected users must maintain awareness of this field safety notice. In these cases, the display of the dose values in the 2D view, including the dose value shown when pointing in the view, maximum dose position, dynamic isodose lines and dose grid display may be incorrect. Customers are encouraged to educate staff and all users about this. For regulatory information, please contact David Hedfors, at +46 8 510 530 12 or david.hedfors@raysearchlabs.com.
Quantity in Commerce 540 units
Distribution US Nationwide Distribution in the states of AZ, AR, CA, CT, DE, FL, GA, HI, IL, LA, MA, MD, MN, MI, MS, MO, NJ, NY, NC, OH, PA, RI, TX & 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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