Elekta, Inc. recalls Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external b…

Recall date

September 15, 2015

Source

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

Recall number

Z-0112-2016

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

Worldwide Distribution -- US, including the states of CA, IN, MI, MO, TX and WI; and, the countries of Australia, Canada, Germany, Greece, India, Netherlands, New Zealand, Turkey, and the UK.

Why it was recalled

Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.

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

What was recalled

Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.