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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 08, 2015
Date Posted May 27, 2015
Recall Status1 Terminated 3 on April 11, 2017
Recall Number Z-1679-2015
Recall Event ID 71289
510(K)Number K120387  K130617  K140187  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment

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. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Code Information Software Version (Build numbers),,,,,,, or
Recalling Firm/
Sveavaegen 9
Stockholm Sweden
Manufacturer Reason
for Recall
RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing.
FDA Determined
Cause 2
Software Design Change
Action RaySearch sent a Device Correction letter dated May 8, 2015 via e-mailed to their customers. The letter identified the affected product, problem, actions to be taken by users and contact information.
Quantity in Commerce Domestic: 539 units
Distribution US Nationwide Distribution
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