WhichRecall
Class IIReported 2026-01-28

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No

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-1105-2026
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
Lot Code: UDI: 0735000201054920220616, 0735000201067920221007, 0735000201073020230913 GTIN: 07350002010549, 07350002010679, 07350002010730 Serial Numbers: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Revisions: RayStation 12A, 12A SP 1, 12A SP2 Expiration Date: 2028-07-07
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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