Recall Z-2899-2020 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
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.
| Date | Jul 29, 2020 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 t |
| Distribution | US Nationwide distribution including in the state of Tennessee. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200487 | RayCare 3.1 RaySearch Laboratories AB (PUBL), Jun 10, 2020 |