RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
- Recall Initiated
- March 3, 2021
- Recall Number
- Z-1281-2021
- Quantity
- 1 unit
Reason for Recall
Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later
Distribution
US Nationwide distribution in the state of TN.
Lot / Code Info
S/N: 3.1.0.60341 Software: RayCare 3B (3.1.0.60341) UDI: 0735000201028020191220;
Root Cause
Software design
Action Taken
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.