Recall Z-1281-2021 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
| Date | Mar 3, 2021 |
| Status | Open, Classified |
| Reason | Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later |
| Root cause | Software design |
| Action | 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 suppor |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200487 | RayCare 3.1 RaySearch Laboratories AB (PUBL), Jun 10, 2020 |