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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 April 07, 2021
Create Date May 14, 2021
Recall Status1 Open3, Classified
Recall Number Z-1598-2021
Recall Event ID 87868
510(K)Number K200569  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product RayStation standalone software radiation therapy treatment planning system.
Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
Code Information Software version number: 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 , 10.1.0.613 
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Sveavagen 9
Stockholm Sweden
Manufacturer Reason
for Recall		 When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.
FDA Determined
Cause 2		 Software design
Action On 04/08/2021, Gore issued an Urgent Medical Device Removal notice to customer via letter notifying them that a Gore Viabil Biliary Endoprosthesis 10 mm x 10 cm device appeared shorter than the labeled length.
Distribution Domestic: TN
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 (publ)
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