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Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is ...

FDA Recall #Z-2684-2017 — Class II — December 13, 2016

Recall #Z-2684-2017 Date: December 13, 2016 Classification: Class II Status: Terminated

Product Description

Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 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

Software issue

Recalling Firm

Ion Beam Applications S.A. — Louvain La Neuve, N/A

Classification

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

Product Type

Devices

Product Quantity

6 worldwide and 5 in the U.S.

Distribution

Distributed to FL, VA, IL, NJ, WA and South Korea

Code Information

Serial Numbers: PAT.006, PAT.108, PAT.112, PAT.113, SAT.116, PAT.003

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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