# FDA recall Z-1930-2019

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2017-11-20.

## Product

RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) .  Intended Use: software system designed for treatment planning and analysis of radiation therapy

## Reason for recall

When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1930-2019
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-20
- **Report date:** 2019-07-10
- **Termination date:** 2023-08-08

- **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-1930-2019

## Citation

> AI Analytics. FDA recall Z-1930-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1930-2019. Source: US FDA. Licensed CC0.

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