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 Initiated
- July 17, 2023
- Posted
- August 25, 2023
- Recall Number
- Z-2464-2023
- Quantity
- 1 install
Reason for Recall
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
Distribution
US Nationwide distribution in the state of TN.
Lot / Code Info
Product name (build number) UDI-DI RayCare 5A (5.0.0.60390) 0735000201039620210524 RayCare 5A SP1 (5.0.1.60052) 0735000201046420220305 RayCare 5B SP1 (5.1.1.60246) 0735000201053220220316 RayCare 5B SP2 (5.1.2.60028) 0735000201062420220613 RayCare 5B SP3 (5.1.3.60023) 0735000201069320221027 RayCare 6A (6.0.0.60553) 0735000201056320220617
Root Cause
Under Investigation by firm
Action Taken
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.