# FDA recall Z-1192-2025

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2025-01-16.

## Product

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System  Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6  Software Version: RayStation 6 Service Pack 1, 2 and 3

## Reason for recall

Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium,  Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain,  SwitzerlandENG, Taiwan, Thailand, UK.

## Key facts

- **Recall number:** Z-1192-2025
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-16
- **Report date:** 2025-02-26

- **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-1192-2025

## Citation

> AI Analytics. FDA recall Z-1192-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1192-2025. Source: US FDA. Licensed CC0.

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