Z-1830-2017 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
April 26, 2017
Initiation Date
March 21, 2017
Termination Date
September 19, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 worldwide, 1 in U.S.

Product Description

Proteus 235, Proton Therapy System

Reason for Recall

In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.

Distribution Pattern

Distribution in US (to Louisiana), and France.

Code Information

Serial Number: SAT.123 (US), and SBF.101 (EU). Versions PTS-9.3.1.2 and PTS-9.4.0