# FDA recall Z-1403-2022

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2022-06-01.

## Product

RayStation 9B SP1. For radiation treatment planning.

## Reason for recall

An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.

## Distribution

Worldwide distribution - US Nationwide distribution in the state of TN and the countries of Belgium and Switzerland.

## Key facts

- **Recall number:** Z-1403-2022
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-06-01
- **Report date:** 2022-07-27
- **Termination date:** 2023-10-04

- **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-1403-2022

## Citation

> AI Analytics. FDA recall Z-1403-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1403-2022. Source: US FDA. Licensed CC0.

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