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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 June 08, 2021
Create Date July 23, 2021
Recall Status1 Terminated 3 on March 20, 2024
Recall Number Z-2138-2021
Recall Event ID 88258
510(K)Number K200569  K200487  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product RayStation (Radiation Treatment Planning System) :
RayStation 9A, 9B, 9B SP1, 10A, 10A
SP1, 10B and 11A, in combination with RayCare
Model Numbers/ UDI:
RayStation 9.0 (9.0.0.113) 07350002010174;
RayStation 9.1 (9.1.0.933) 07350002010266;
RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297;
RayStation 10.0 (10.0.0.1154) 07350002010303;
RayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365;
RayStation 10.1 (10.1.0.613) 07350002010310;
RayStation 11.0 (11.0.0.951) 07350002010389;
Code Information Product name (build number) UDI-DI RayStation 9.0 (9.0.0.113) 07350002010174 RayStation 9.1 (9.1.0.933) 07350002010266 RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297 RayStation 10.0 (10.0.0.1154) 07350002010303 RayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365 RayStation 10.1 (10.1.0.613) 07350002010310 RayStation 11.0 (11.0.0.951) 07350002010389
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Sveavagen 9
Stockholm Sweden
Manufacturer Reason
for Recall		 Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.
FDA Determined
Cause 2		 Under Investigation by firm
Action RaySearch issued Urgent Field Safety Notice, Medical Device Correction #80230 via email on 06/08/21. Letter states reason for recall, health risk and action to take: TO BE TAKEN BY THE USER " Do not create setup beams with the localization point as isocenter (option 2). " Always perform secondary verification of new treatment positions. RayTreat will notify the user when the treatment positions have been updated. " Always perform imaging before treating the patient. " Educate planning staff and all users about this workaround. " Inspect your product and identify all installed units with the above software version number(s). " Confirm you have read and understood this notice by replying to the notification email. SOLUTION This issue will be resolved in the next version of RayStation, scheduled for market release in June 2021 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use. For regulatory information, please contact quality@raysearchlabs.com.
Quantity in Commerce 5 units
Distribution US distribution to TN; and Belgium
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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