Elekta Inc recalls Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to mak…

Recall date

April 16, 2020

Source

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

Recall number

Z-1825-2020

FDA classification

Class II

Brand / firm

Elekta Inc

Sold / distributed

Worldwide distribution - US Nationwide Distribution in the states of IA, NJ, NY, PA, TX, WI and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, United Kingdom.

Why it was recalled

The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate 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

Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The