# FDA recall Z-1102-2026

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

## Product

RayStation/RayPlan. Model/Catalog Number: 10.1.   Software Version: RayStation/RayPlan 10B.    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-1102-2026
- **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-1102-2026

## Citation

> AI Analytics. FDA recall Z-1102-2026. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1102-2026. Source: US FDA. Licensed CC0.

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