Recall Z-0206-2024 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care Product name (build number): (1)RayCare 5B SP1 (5.1.1.60246); (2)RayCare 5B SP3 (5.1.3.60023); (3) RayCare 6A (6.0.0.60553)
| Date | Nov 1, 2023 (initiated Sep 12, 2023) |
| Status | Open, Classified |
| Reason | An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace when using document fields configured with single- or multi-selectable values. |
| Root cause | Under Investigation by firm |
| Action | Raysearch issued Field Safety Notice, Medical Device Correction #121600 via email on 9/12/23. Letter states reason for recall, health risk and action to take: Educate staff and all users to open configurable documents from the Documents workspace to avoid the issue. " Review all configured documents and consider reconfiguration in a way that will not trigger the issue. " 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. Solution This issue will be resolved in |
| Quantity | 2 sytems |
| Distribution | MD, 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 |