Elekta Inc recalls Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make tre…

Recall date

September 4, 2019

Source

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

Recall number

Z-2560-2019

FDA classification

Class II

Brand / firm

Elekta Inc

Sold / distributed

Worldwide Distribution - US Nationwide in the states of WI, OH, NY, OH, IN, IA, TX, and countries of Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, UK

Why it was recalled

It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.

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 RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review