Ion Beam Applications S.A. recalls Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed…

Recall date

June 27, 2018

Source

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

Recall number

Z-2470-2018

FDA classification

Class II

Brand / firm

Ion Beam Applications S.A.

Sold / distributed

US Nationwide Distribution in the states of FL, VA, PA, OK, NJ, WA, and TX.

Why it was recalled

Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This can lead to risk of crushing for patient and/or user, and risk of mistreatment for the patient.

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, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver 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.