# FDA recall Z-2138-2021

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2021-06-08.

## Product

RayStation (Radiation Treatment Planning System) :  RayStation 9A, 9B, 9B SP1, 10A, 10A  SP1, 10B and 11A, in combination with RayCare  Model Numbers/ UDI:  RayStation 9.0 (9.0.0.113)   07350002010174;  RayStation 9.1 (9.1.0.933)   07350002010266;  RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297;  RayStation 10.0 (10.0.0.1154) 07350002010303;  RayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365;  RayStation 10.1 (10.1.0.613) 07350002010310;  RayStation 11.0 (11.0.0.951) 07350002010389;

## Reason for recall

Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.

## Distribution

US distribution to TN; and Belgium

## Key facts

- **Recall number:** Z-2138-2021
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-08
- **Report date:** 2021-08-04
- **Termination date:** 2024-03-20

- **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-2138-2021

## Citation

> AI Analytics. FDA recall Z-2138-2021. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2138-2021. Source: US FDA. Licensed CC0.

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