RAYSEARCH LABORATORIES AB recalls Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning an…

Recall date

May 29, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2785-2015

FDA classification

Class II

Brand / firm

RAYSEARCH LABORATORIES AB

Sold / distributed

Worldwide Distribution: US (nationwide) to state of WA; and countries of: France, Sweden, Austria, Spain, Germany, Italy, UK, New Zealand.

Why it was recalled

An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Radiation Therapy Treatment Planning System software 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.