Recall – Proteus 235

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

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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Corporate Office

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