RayStation Software (RaySearch) – UID uniqueness (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A, Software Version: 8.0.0.61. 3. RayStation 8A Service Pack 1, Software Version: 8.0.1.10. Product Description: Radiation Therapy Treatment Planning System.
Brand
RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden
Lot Codes / Batch Numbers
1. Software Version: 7.0.0.19, UDI: 0735000201006820171130. 2. Software Version: 8.0.0.61, UDI: 0735000201011220180608. 3. Software Version: 8.0.1.10, UDI: 0735000201013620180928. Expiration Date: 2023-10-04
Products Sold
1. Software Version: 7.0.0.19, UDI: 0735000201006820171130. 2. Software Version: 8.0.0.61, UDI: 0735000201011220180608. 3. Software Version: 8.0.1.10, UDI: 0735000201013620180928. Expiration Date: 2023-10-04
RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden is recalling RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. due to DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Recommended Action
Per FDA guidance
RaySearch 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026