RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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 above software version number(s). " Confirm that you have read and understood this notice by replying to the notification email. SOLUTION This issue is resolved in the RayCare 2023B, market released in July 2023 (subject to market clearance in some markets) and future versions. If customers wish to continue using versions of RayCare affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use. For regulatory information, please contact quality@raysearchlabs.com.