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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 FirmNovember 28, 2025
Date PostedJanuary 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1103-2026
Recall Event ID 98117
510(K)NumberK211867 
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
ProductRayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System
Code Information Lot Code: UDI: 0735000201038920210518, 0735000201043320210610, 0735000201044020210916, 35000201063120220616. GTIN: 07350002010389, 07350002010433, 07350002010440, 07350002010631. Serial Numbers: 11.0.0.951, 11.0.1.29, 11.0.3.116, 11.0.4.15. Software Revision: RayStation 11A, 11A SP1, 11A SP2, 11A SP3. Expiration Date: 2027-06-22.
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Eugeniavagen 18c
Stockholm Sweden
For Additional Information ContactPierpaolo Sesana
0046-85-1053000
Manufacturer Reason
for Recall		Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
FDA Determined
Cause 2		Under Investigation by firm
ActionRaySearch Laboratories notified consignees via email on about 12/05/2025. Consignees were instructed to follow the outlined steps in the notification letter when adding geometry to an empty ROI with MO or type Bolus, Fixation or Support, educate planning staff and all users about the workaround, inspect units and identify all installed units with the affected software version numbers, and confirm receipt and understanding of the customer notification by responding to the notification email. The issue will be resolved in the next version of RayStation, scheduled for market release in December 2025 (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. The upgrade to an unaffected software version will be scheduled in coordination with the authorized personnel, considering the specific circumstances and requirements of each individual case. The upgrade may be conducted remotely or onsite, as deemed appropriate.
Quantity in Commerce10 units
DistributionRefer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MUJ
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