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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.