Recall Z-2464-2023 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayCare software, include version number 5A, 5B, 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. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2, 5.1.3, 6.0.0
| Date | Aug 25, 2023 (initiated Jul 17, 2023) |
| Status | Open, Classified |
| Reason | An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances |
| Root cause | Under Investigation by firm |
| Action | RaySearch issued Field Safety Notice, Medical Device Correction #119464 Letter via E-mail, on July 17, 2023. Letter states reason for recall, health risk and action to take: Manually verify the patient s medication list with respect to included substances when adding an new allergy to a medication substance. " Make sure to update all medications when activating a new version of the drug ingredients value set in the RayCare admin interface. " Educate staff and all users about the absence of a warning when adding a patient allergy. " Inspect your product and identify all installed units with the |
| Quantity | 1 install |
| 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 |