RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.
Brand
RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden
Lot Codes / Batch Numbers
Model #: 2C SP2, 2C SP3, 3A SP1, 3B and 4A Software Version: 2.2.2.30782, 2.2.3.53423, 3.0.1.43597, 3.1.0.60341, 4.0.0.60621"
Products Sold
Model #: 2C SP2, 2C SP3, 3A SP1, 3B and 4A Software Version: 2.2.2.30782 , 2.2.3.53423 , 3.0.1.43597 , 3.1.0.60341 , 4.0.0.60621"
RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden is recalling RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, a due to When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the planning image selected. When starting the task, an error message might be displayed stating: Review files not available.
Recommended Action
Per FDA guidance
Only 1 effected consignee who was emailed a field safety notice on 08/05/2020. This letter instructs the user to: Be aware that registration of a treatment image with a corresponding study with multiple series in the same frame of reference might block the offline image review. Verify the correctness of the data in RayCare PACS before using the data for any decision making. -Please educate 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.
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