RayStation/RayPlan — Class II medical device recall Z-1104-2026

Ongoing recall by RAYSEARCH LABORATORIES AB, reported 2026-01-28. Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of

Recall number	`Z-1104-2026`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	RAYSEARCH LABORATORIES AB, Stockholm, Sweden
Recall initiated	2025-11-28
Classified	2026-01-16
Reported by FDA	2026-01-28
Quantity	22 units
UPC / GTIN / UDI-DI	`07350002010426`, `07350002010495`, `07350002010501`, `07350002010570`, `07350002010600`
Serial numbers	`12.0.0.932`, `12.0.3.68`, `12.0.4.12`, `12.1.0.1221`, `12.3.0.119`
Model numbers	`12.0.0`, `12.0.3`, `12.0.4`, `12.1.0`, `12.3.0`
Expiration dates	`2028-03-20`

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1104-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.