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Recall Observatory FDA recall evidence

Device product

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

Z-1102-2026

November 28, 2025

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 98117
Status
Ongoing
Classification
Class II
Quantity
0
Official record key
device-enforcement:Z-1102-2026

Official wording

Reason: 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.

Code information: UDI: 0735000201031020201216. GTIN: 07350002010310. Serial Numbers: 10.1.0.613. Software Revision: RayStation 10B. Expiration Date: 2027-02-01.

Distribution pattern: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.