Ion Beam Applications S.A. recalls Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for…

Recall date

April 10, 2017

Source

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

Recall number

Z-2097-2017

FDA classification

Class II

Brand / firm

Ion Beam Applications S.A.

Sold / distributed

FL

Why it was recalled

A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered 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

Proton therapy system -Proteus 235 aka Proteus Plus. 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.