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U.S. Department of Health and Human Services

Class 2 Device Recall RaySearch

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 Class 2 Device Recall RaySearchsee related information
Date Initiated by FirmSeptember 09, 2021
Create DateMarch 31, 2022
Recall Status1 Terminated 3 on April 16, 2024
Recall NumberZ-0848-2022
Recall Event ID 89788
510(K)NumberK210645 
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
ProductTomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29.
Code Information Name (build number) UDI-DI: RayStation 6/RayPlan 2 Service Pack 1 (6.1.0.26) 07350002010037 RayStation 6/RayPlan 2 Service Pack 1 v.6.1.1 (6.1.1.2) 07350002010082 RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) 07350002010075 RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) 07350002010242 RayStation/RayPlan 7 (7.0.0.19) 07350002010068 RayStation/RayPlan 8A (8.0.0.61) 07350002010112 RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) 07350002010136 RayStation/RayPlan 8B (8.1.0.47) 07350002010129 RayStation/RayPlan 8B Service Pack 1 (8.1.1.8) 07350002010204 RayStation/RayPlan 8B Service Pack 2 (8.1.2.5) 07350002010235 RayStation 9A (9.0.0.113) 07350002010174 RayStation 9B (9.1.0.933) 07350002010266 RayStation Service Pack 1 (9.2.0.483) 07350002010297 RayStation 10A (10.0.0.1154) 07350002010303 RayStation 10A Service Pack 1 (10.0.1.52) 07350002010365 RayStation 10B (10.1.0.613) 07350002010310 RayStation 11A (11.0.0.951) 07350002010389 RayStation 11A Service Pack 1 (11.0.1.29) 07350002010433
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Sveavagen 9
Stockholm Sweden
Manufacturer Reason
for Recall		If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning
FDA Determined
Cause 2		Under Investigation by firm
ActionRaySearch issued Field Safety Notice, Medical Device Correction #83773 notice via email on Sept. 9, 2021. Letter states reason for recall, health risk and action to take: ACTIONS TO BE TAKEN BY THE USER " Avoid changing the dose grid after starting an optimization of TomoHelical and TomoDirect plans with dynamic jaw mode. " Always reset the optimization after editing the dose grid for TomoHelical and TomoDirect plans with dynamic jaw mode. " Always reset the optimization after modifying the target ROI. " It is recommended to use the BEV to inspect the jaw positions superior and inferior to the target dynamic jaw mode. " 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 October 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 Commerce51 (US) Licenses
DistributionUS Nationwide distribution in the states of AL, CA, FL, GA, IA, IL, MO, MS, NC, OK, OR, SC, TN, WA, WI.
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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