FDA Device

Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0

Hazard

Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.

What You Should Do

Remedy

Medical Device Correction Letters dated 10/23/13 were e-mailed to the user accounts on 10/23/13.

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Products

Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Brand
RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden
UPC
Software version and build numbers 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4.

Units Affected

195 units domestically

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