# FDA recall Z-1464-2020

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2020-02-20.

## Product

RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system

## Reason for recall

There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.

## Distribution

The products were distributed to the following US states: TN

## Key facts

- **Recall number:** Z-1464-2020
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-20
- **Report date:** 2020-03-18
- **Termination date:** 2024-11-05

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1464-2020

## Citation

> AI Analytics. FDA recall Z-1464-2020. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1464-2020. Source: US FDA. Licensed CC0.

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