RAYSEARCH LABORATORIES AB recalls Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment plann…

Recall date

October 11, 2016

Source

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

Recall number

Z-0720-2017

FDA classification

Class II

Brand / firm

RAYSEARCH LABORATORIES AB

Sold / distributed

US Nationwide Distribution in the states of AZ, AR, CA, CT, DE, FL, GA, HI, IL, LA, MA, MD, MN, MI, MS, MO, NJ, NY, NC, OH, PA, RI, TX & WA

Why it was recalled

An error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in RayStation 5. If a CT image set with the same Frame of Reference as the displayed auxiliary CT set exists in another case, the dose display may be incorrect. When the error occurs, the display of dose in patient views, including the maximum dose position, the dynamic isodose lines and the dose grid may be incorrect. The dose value normally displayed in the upper left corner when pointing in the 2D view may be incorrect or missing.

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 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.