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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 March 28, 2018
Create Date June 26, 2018
Recall Status1 Terminated 3 on May 27, 2020
Recall Number Z-2290-2018
Recall Event ID 80252
510(K)Number K171536  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0

Product Usage: 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 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 and 7.0.0.19
Recalling Firm/
Manufacturer
RAYSEARCH LABORATORIES AB
Sveavagen 9
Stockholm Sweden
Manufacturer Reason
for Recall
The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.
FDA Determined
Cause 2
Software design
Action On March 28, 2018, the firm issued a Field Safety Notice, Medical Device Correction letter to its affected customers. The firm instructed users to take the following actions: -Do not use MLC only collimated to set output factor corrections (OFCs) in beam modeling of Elekta Synergy machines with MLCi/MLCi2 or any other machine with the MLC closer to the source than both the x- and y-jaws. Always use ¿Jaws and MLC collimated¿. -Be aware that there is an error in the field measure calculation for machines with the MLC closer to the source than both the x- and y-jaws, and for machines with fixed jaws. Make sure to perform patient-specific QA before treatment delivery for treatment plans with fields where: 1) closed MLC leaves are positioned inside the jaw field and 2) the minimum static/dynamic tip gap is larger than 0.001 cm. Please educate planning staff and all users about this workaround. Inspect your product and identify all installed units with the above software version number(s), then confirm you have read and understood this information by replying to the notification email. This issue will be resolved in the next version of RayStation/RayPlan, scheduled for market release in June 2018 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation/RayPlan affected by this Field Safety Notice, all users must maintain awareness of this Field Safety Notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use.
Quantity in Commerce 728
Distribution US Nationwide Distribution in the states of AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, ID, IL, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, VT, WA, WI.
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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