Z-1830-2017 Class II Terminated
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