Ion Beam Applications S.A. recalls Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients wit…

Recall date

August 7, 2016

Source

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

Recall number

Z-2173-2018

FDA classification

Class II

Brand / firm

Ion Beam Applications S.A.

Sold / distributed

Units were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Each country's national Competent Authorities have been informed.

Why it was recalled

IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.

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 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.