# FDA recall Z-1281-2021

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2021-03-03.

## Product

RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.

## Reason for recall

Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later

## Distribution

US Nationwide distribution in the state of TN.

## Key facts

- **Recall number:** Z-1281-2021
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-03-03
- **Report date:** 2021-03-31

- **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-1281-2021

## Citation

> AI Analytics. FDA recall Z-1281-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1281-2021. Source: US FDA. Licensed CC0.

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