Elekta, Inc. recalls Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensio…

Recall date

May 21, 2015

Source

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

Recall number

Z-1712-2015

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NC, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WV, WI, Argentina, Australia, Bangladesh, Belarus, Botswana, Brazil, Canada, Chile, China, Colombia, Ecuador, Egypt, Guatemala, Hong Kong,…

Why it was recalled

Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.

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 Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.