Elekta Inc recalls Monaco Radiation Treatment Planning System (RTP) System

Recall date

November 22, 2019

Source

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

Recall number

Z-0670-2020

FDA classification

Class II

Brand / firm

Elekta Inc

Sold / distributed

IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom.

Why it was recalled

Monaco is using the incorrect energy when optimizing and calculating dose.

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 (RTP) System