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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 July 17, 2017
Create Date January 17, 2018
Recall Status1 Terminated 3 on August 29, 2018
Recall Number Z-0380-2018
Recall Event ID 78900
510(K)Number K171536  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product RayStation

Product Usage: 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 6.0.0.24 , 6.1.0.26 , 6.1.1.2 or 6.2.0.7
Recalling Firm/
Manufacturer
RAYSEARCH LABORATORIES AB
Sveavaegen 9
Stockholm Sweden
Manufacturer Reason
for Recall
For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.
FDA Determined
Cause 2
Device Design
Action Ray Search sent a Field Safety Notice letter dated July 14, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter included a response form with instructions for workarounds until the software is corrected.
Quantity in Commerce 117 units
Distribution US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.
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 (publ)
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