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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 October 23, 2013
Date Posted November 14, 2013
Recall Status1 Terminated 3 on February 17, 2017
Recall Number Z-0281-2014
Recall Event ID 66600
510(K)Number K120387  K130617  
Product Classification Radiation Therapy Treament Planning System - Product Code MUJ
Product Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Code Information Software version and build numbers 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4.
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Sveavaegen 9
Stockholm Sweden
Manufacturer Reason
for Recall		 Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
FDA Determined
Cause 2		 Software design
Action Medical Device Correction Letters dated 10/23/13 were e-mailed to the user accounts on 10/23/13.
Quantity in Commerce 195 units domestically
Distribution US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia.
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
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