# FDA recall Z-2489-2025

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2025-08-08.

## Product

RayStation with the following product descriptions:     1. RayStation 9B, Software Version: 9.1.0.933.    2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483.    3. RayStation 10A, Software Version: 10.0.0.1154.    4. RayStation 10A Service Pack 1, Software Version: 10.0.1.52.    5. RayStation 10A Service Pack 2, Software Version: 10.0.2.10.      Product Description: Radiation Therapy Treatment Planning System.

## Reason for recall

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

## Distribution

Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey, UK, Ukraine.

## Key facts

- **Recall number:** Z-2489-2025
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-08
- **Report date:** 2025-09-10

- **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-2489-2025

## Citation

> AI Analytics. FDA recall Z-2489-2025. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-2489-2025. Source: US FDA. Licensed CC0.

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