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Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus...

FDA Recall #Z-0698-2019 — Class II — December 12, 2018

Recall #Z-0698-2019 Date: December 12, 2018 Classification: Class II Status: Terminated

Product Description

Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) 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.

Reason for Recall

There is a risk of detachment of the Compact Gantry Rolling Floor.

Recalling Firm

Ion Beam Applications S.A. — Louvain-la-neuve

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

7

Distribution

Worldwide Distribution - US Nationwide in the states of LA and MI. Foreign distribution to France, Japan, and UK.

Code Information

SAT.123, SBF.101, SBF.103, SBF.104, SBF.105, SBF.107, SBF.109

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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