Ion Beam Applications S.A. recalls Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of…

Recall date

November 17, 2017

Source

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

Recall number

Z-0938-2018

FDA classification

Class II

Brand / firm

Ion Beam Applications S.A.

Sold / distributed

Nationally

Why it was recalled

There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.

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

What was recalled

Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.