RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden RayStation 9B SP1. For radiation treatment planning. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RayStation 9B SP1. For radiation treatment planning.
Brand
RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden
Lot Codes / Batch Numbers
UDI-DI: 0735000201029720200310 Build number 9.2.0.483
Products Sold
UDI-DI: 0735000201029720200310 Build number 9.2.0.483
RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden is recalling RayStation 9B SP1. For radiation treatment planning. due to An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, informa. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.
Recommended Action
Per FDA guidance
The firm contacted all customers via email on June 1, 2022. Customers were provided with a list of workflows where safety related information may not be propagated. Customers were instructed to be aware that treatment course information in RayCare may not always be up to date. Customers should verify critical information in RayStation or RayTreat before treatment course information in RayCare is used for critical decisions. Customers were asked to identify all installed units with the affected software version numbers. The issue will be resolved in mandatory software updates for RayStation, scheduled for market release in June 2022.
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