RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
Brand
RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden
Lot Codes / Batch Numbers
S/N: 3.1.0.60341 Software: RayCare 3B (3.1.0.60341) UDI: 0735000201028020191220
Products Sold
S/N: 3.1.0.60341 Software: RayCare 3B (3.1.0.60341) UDI: 0735000201028020191220;
RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden is recalling RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports hea due to Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later
Recommended Action
Per FDA guidance
Raysearch issued via E-mail on 03 March 2021, Field Safety Notice, Medical Device Correction #75198 letter stating reason for recall, health risk and action to take: RaySearch will check if the issue affects your system and apply the below solution. " Until the solution has been applied, be aware that the message body is missing from messages created in RayCare 2. " Confirm you have read and understood this notice by replying to the notification email. For regulatory information, please contact quality@raysearchlabs.com SOLUTION This issue will be resolved by RaySearch staff using a support tool. Using the support tool, the message body will be restored to all messages in the currently used RayCare version.
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