FDA Device

RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of

Hazard

RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing.

What You Should Do

Remedy

RaySearch sent a Device Correction letter dated May 8, 2015 via e-mailed to their customers. The letter identified the affected product, problem, actions to be taken by users and contact information.

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Products

RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatmen
Brand
RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden
UPC
Software Version (Build numbers) 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, or 4.0.3.4

Units Affected

Domestic: 539 units

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