# FDA recall Z-1744-2024

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2024-03-28.

## Product

RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.

## Reason for recall

Potential for reported SSD to be too high.

## Distribution

Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.

## Key facts

- **Recall number:** Z-1744-2024
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-28
- **Report date:** 2024-05-08

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1744-2024

## Citation

> AI Analytics. FDA recall Z-1744-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1744-2024. Source: US FDA. Licensed CC0.

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