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U.S. Department of Health and Human Services

Class 2 Device Recall RayStation Therapy Treatment Planning System

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  Class 2 Device Recall RayStation Therapy Treatment Planning System see related information
Date Initiated by Firm February 15, 2013
Date Posted May 28, 2013
Recall Status1 Open3, Classified
Recall Number Z-1419-2013
Recall Event ID 65136
510(K)Number K120387  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment.

RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Code Information Software version and build numbers 2.0.0.15, 2.5.1.89, and 3.0.0.251 (to determine if the version used is affected, bring up the About box in the RayStation application and check the build number reported0.
Recalling Firm/
Manufacturer
RAYSEARCH LABORATORIES AB
Sveavaegen 9
Stockholm Sweden
Manufacturer Reason
for Recall
Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning.
FDA Determined
Cause 2
Software change control
Action RaySearch Laboratories sent an Urgent Field Safety Notice, Medical Device Correction letter dated January 28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to educate their planning staff and all users about the recommended workarounds contained in the letter. Customers were also asked to inspect their product and identify all installed units that were infected and then complete the attached Reply Form and e-mail or scan a copy of the completed form to the firm. Customers were instructed to pass along this information to all those who need to be aware of this Medical Device Correction Customers with questions were instructed to contact the RaySearch support email at support@raysearchlabs. For questions regarding this recall call +46 8 545 06130.
Quantity in Commerce Domestic: 70 units; Foreign: 27 units
Distribution Worldwide Distribution - USA including Connecticut, Florida, Massachusetts, Missouri, New York, Ohio, and foreign distribution to(Canada, Italy, Australia, Germany, Netherlands, and Switzerland.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = RAYSEARCH LABORATORIES AB
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