Z-1830-2017 Class II Terminated
FDA device recall Z-1830-2017 was initiated by Ion Beam Applications S.A. on March 21, 2017 and is designated Class II. Reason for recall: In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data. The recall status is terminated (terminated September 19, 2018). Affected quantity: 2 worldwide, 1 in U.S..
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