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U.S. Department of Health and Human Services

Class 2 Device Recall RayStation 4.7.

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  Class 2 Device Recall RayStation 4.7. see related information
Date Initiated by Firm May 29, 2015
Date Posted September 17, 2015
Recall Status1 Terminated 3 on March 13, 2017
Recall Number Z-2785-2015
Recall Event ID 71477
510(K)Number K141860  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product Radiation Therapy Treatment Planning System software

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 software build numbers are 4.7.0.15 or 4.7.1.10
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Sveavaegen 9
Stockholm Sweden
Manufacturer Reason
for Recall		 An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images
FDA Determined
Cause 2		 Software design
Action The firm, RaySearch Laboratories, distributed a "Field Safety Notice, Medical Device Correction #7106" notice dated May 29, 2015,and reply forms to their customers via email. The notice describes the product, problem and actions to be taken. The Customers were provided a workaround as a temporary fix. Customers were also instructed to educate all users, inspect your product and identify all installed units, confirm you have read and understood the notice by contacting Quality and Regulatory Affairs Manager; and complete and return the reply form via email to freddie.cardel@raysearchlabs.com or by fax to 888-501-7195. The solution will be resolved in the next version of RayStation, scheduled for release in June 2015. Customers were advised to share the notice to all those who need to be aware within the organizations. Customers can contact Quality and Regulatory Affairs Manager at +46 8 510 530 12 or via email at david.hedfors@raysearchlabs.com.
Quantity in Commerce 20 devices
Distribution Worldwide Distribution: US (nationwide) to state of WA; and countries of: France, Sweden, Austria, Spain, Germany, Italy, UK, New Zealand.
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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