# FDA recall Z-1104-2026

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2025-11-28.

## Product

RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0.   Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1.     Radiation Therapy Treatment Planning System

## Reason for recall

Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

## Distribution

Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS

## Key facts

- **Recall number:** Z-1104-2026
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-28
- **Report date:** 2026-01-28

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1104-2026

## Citation

> AI Analytics. FDA recall Z-1104-2026. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1104-2026. Source: US FDA. Licensed CC0.

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