FDA-Device2026-01-28Class IIPROCESSING DEFECT

RaySearch RayStation 10.1.1 radiation therapy software recalled for dose calculation error

OTHERNationwide distribution

Update RaySearch RayStation software immediately

RaySearch's RayStation radiation therapy planning software version 10B SP1 has a flaw where calculated radiation doses may not update correctly when certain regions of interest are modified. This affects regions with no contours that have material overrides or are classified as Bolus, Fixation, or Support types. Clinical staff may unknowingly rely on outdated dose calculations.

Identify any RayStation version 10.1.1 systems in use at your facility
Contact RaySearch for the software update or patch
Verify dose calculations manually for affected regions of interest before treatment
Update to the corrected software version as soon as possible

Hazard

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.

Sold states

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

Affected count

Manufactured in

Eugeniavagen 18c, Stockholm, Sweden

Products

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1107-2026

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