Elekta, Inc. recalls Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analy…

Recall date

December 23, 2016

Source

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

Recall number

Z-0987-2017

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide in the states of AL, CA, DC, NE, NY, ND, OR, PA, RI, SC, TX, and the countries of Angola, Argentina, Armenia, Australia, Austria, Barbados, Belarus, Brazil, Bulgaria, Canada, China Columbia, Curacao, Czech Republic, Denmark, Finland, France, Germany, Greece, H…

Why it was recalled

Cross profile for Varian 60 degree wedge shows "horns."

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

What was recalled

Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.