# FDA recall Z-0294-2019

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2018-09-21.

## Product

RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a  stand-alone software treatment planning system.

## Reason for recall

Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0294-2019
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-21
- **Report date:** 2018-11-07
- **Termination date:** 2020-06-16

- **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-0294-2019

## Citation

> AI Analytics. FDA recall Z-0294-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0294-2019. Source: US FDA. Licensed CC0.

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