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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 November 09, 2016
Create Date December 08, 2016
Recall Status1 Terminated 3 on June 11, 2019
Recall Number Z-0721-2017
Recall Event ID 75731
510(K)Number K160093  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System

Product Usage:
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. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Code Information Build numbers: 4.0.2.9, 4.0.3.4, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11 or 5.0.2.35
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Sveavaegen 9
Stockholm Sweden
Manufacturer Reason
for Recall		 Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation in RayStation 4.0, 4.5, 4.7 and 5.0. For treatment plans with a combination of range shifter, large air gap and beams that enter the patient surface at an oblique angle, the dose calculation accuracy may be less than expected.
FDA Determined
Cause 2		 Software design
Action Ray Search sent an Urgent Field Safety Notice Medical Device Correction letter (dated 11/8/2016) via e-mailed to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to Inspect their product and identify all installed units with the above software version number, then confirm you have read and understood this notice (contact information included).
Quantity in Commerce US: 66 units
Distribution US Nationwide Distribution in the states of California, Florida, Illinois, Louisiana, Michigan, New Jersey, Tennessee, Texas, Washington
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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