# FDA recall Z-2464-2023

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2023-07-17.

## 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

- **Recall number:** Z-2464-2023
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-17
- **Report date:** 2023-09-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Stockholm, N/A, Sweden

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-2464-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2464-2023. Source: US FDA. Licensed CC0.

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