WhichRecall
Class IIReported 2026-01-28

RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System

Recalled by RAYSEARCH LABORATORIES AB

Reason for Recall

Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs)

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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.

Recall Number
Z-1102-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-28
Reported
2026-01-28
Distribution
Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
Code Info
UDI: 0735000201031020201216. GTIN: 07350002010310. Serial Numbers: 10.1.0.613. Software Revision: RayStation 10B. Expiration Date: 2027-02-01.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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