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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 RayStationsee related information
Date Initiated by FirmJune 08, 2021
Create DateJuly 23, 2021
Recall Status1 Terminated 3 on March 20, 2024
Recall NumberZ-2138-2021
Recall Event ID 88258
510(K)NumberK200487 K200569 
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
ProductRayStation (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
ActionRaySearch 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 Commerce5 units
DistributionUS distribution to TN; and Belgium
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MUJ
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