FDA Device

RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.

Hazard

This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.

What You Should Do

Remedy

On April 25, 2014, RaySearch emailed all consignees of the affected product a copy of the recall notice as well as the response forms. Back up notification methods include phone calls and site visits.

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Products

RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Brand
RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden
UPC
Software version 4.0.3.4

Units Affected

25 sites/245 units (US), 25 sites/124 units (foreign)

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