# FDA recall Z-2899-2020

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2020-07-29.

## Product

RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.

## Reason for recall

When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the planning image selected. When starting the task, an error message might be displayed stating: Review files not available.

## Distribution

US Nationwide distribution including in the state of Tennessee.

## Key facts

- **Recall number:** Z-2899-2020
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-07-29
- **Report date:** 2020-09-02

- **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-2899-2020

## Citation

> AI Analytics. FDA recall Z-2899-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2899-2020. Source: US FDA. Licensed CC0.

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