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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 FirmAugust 08, 2025
Date PostedSeptember 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2492-2025
Recall Event ID 97400
510(K)NumberK220141 
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
ProductRayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68. 4. RayStation 11B Service Pack 3, Software Version: 12.0.4.12. 5. RayStation 11B Service Pack Toshiba 1, Software Version: 12.3.0.119. Product Description: Radiation Therapy Treatment Planning System.
Code Information 1. Software Version: 12.0.0.932, UDI: 0735000201042620211208. 2. Software Version: 12.1.0.1221, UDI: 0735000201049520220312. 3. Software Version: 12.0.3.68, UDI: 0735000201050120220422. 4. Software Version: 12.0.4.12, UDI: 0735000201060020220620. 5. Software Version: 12.3.0.119, UDI: 0735000201057020221222. Expiration Date: 2028-03-20
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Eugeniavagen 18c
Stockholm Sweden
For Additional Information ContactPierpaolo Sesana
0046-85-1053000
Manufacturer Reason
for Recall		DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
FDA Determined
Cause 2		Under Investigation by firm
ActionRaySearch notified consignees on about 08/08/2025 via email. Consignees were informed that as temporary solution, affected objects can be re-exported via RayGateway to generate new UIDs. They were instructed to inform planning staff and all users about this workaround, inspect your product and identify all installed units with the above software version number(s), and complete and return the response form. 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.
Quantity in Commerce6
DistributionWorldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey, UK, Ukraine.
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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