RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user nee Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user nee
Brand
RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden
Lot Codes / Batch Numbers
Software version numbers: 4.0.0.14, 4.0.3.4, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 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
Products Sold
Software version numbers: 4.0.0.14 , 4.0.3.4 , 4.5.1.14 , 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 4.7.6.7 , 4.9.0.42 ,; 5.0.1.11 , 5.0.2.35 , 5.0.3.17 , 6.0.0.24 , 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
RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden is recalling RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6. due to If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the ref. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI.
Recommended Action
Per FDA guidance
On October 8, 2020, the firm emailed "Field Safety Notice, Medical Device Correction #66704" to affected customers. Customers were made aware of the product issue and asked to take the following actions: " Do not exclude the prescription ROI or POI when exporting from RayStation with the Exclude from export option. " If an RT Structure Set where it is not certain that all referenced bolus and prescription ROIs or POIs are present is imported to RayStation, make sure to check that any intended references to bolus and prescription are correct after import. " Please 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. This issue will be resolved in the next version of RayStation, scheduled for market release in November 2020 (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
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