Recall – Proton Therapy System

Company: Ion Beam Applications S.A.
Date of Enforcement Report: 7/18/2018
Class II:

PRODUCT
Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A 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.

Recall Number: Z-2424-2018

REASON
Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.

RECALLING FIRM/MANUFACTURER
Ion Beam Applications S.A, Louvain La Neuve . on 5/16/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3 units

DISTRIBUTION
US Nationwide in the states of FL and the countries of Sweden, The Netherlands

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