FDA recall Z-2464-2023

RAYSEARCH LABORATORIES AB · Class II · device

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

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.

Key facts

Status
Ongoing
Initiation date
2023-07-17
Report date
2023-09-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Stockholm, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2464-2023