Aug

2023

FDA Recall: Sofftware Issue- Warning Not Being Displayed

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.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: Sofftware Issue- Warning Not Being Displayed

Allison Pate

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