FDA recall Z-1104-2026

RAYSEARCH LABORATORIES AB · Class II · device

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

Status: Ongoing
Initiation date: 2025-11-28
Report date: 2026-01-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Stockholm, Sweden

Primary source

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