RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)
Brand
RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden
Lot Codes / Batch Numbers
Software version: 9A, 9B, 10A, 10B
Products Sold
Software version: 9A, 9B, 10A, 10B
RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden is recalling RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.115 due to Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
Recommended Action
Per FDA guidance
On 03/25/2021, RaySearch Laboratories issued an Urgent Medical Device Correction notice via email to their customer notifying them of an issue found with the display of flags in RayTreat. Flags edited in RayCare after a patient has been checked in, may not be updated in RayTreat.
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