Elekta, Inc. recalls Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation tre…

Recall date

December 18, 2015

Source

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

Recall number

Z-0604-2016

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide in the states of CA, NY, PA, and the countries of Austria, Belarus, Canada, China, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Netherlands, Norway, Poland, South Korea, Spain, Sweden and United Kingdom.

Why it was recalled

When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and open jaws in areas away from the target volume.

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 - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.