Company: RAYSEARCH LABORATORIES AB
Date of Enforcement Report: 08/25/2023
Class II
PRODUCT
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 Number:
Z-2464-2023
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
RECALLING FIRM/MANUFACTURER:
RAYSEARCH LABORATORIES AB
VOLUME OF PRODUCT IN COMMERCE:
1 install
DISTRIBUTION:
US Nationwide distribution in the state of TN.
