PlainRecalls
FDA Devices Moderate Class II Terminated

The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)

Reported: July 4, 2018 Initiated: April 11, 2016 #Z-2284-2018

Product Description

The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)

Reason for Recall

IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.

Details

Units Affected
2
Distribution
Units were distributed to Korea and Jacksonville, FL.
Location
Louvain La Neuve

Frequently Asked Questions

What product was recalled?
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS). Recalled by Ion Beam Applications S.A.. Units affected: 2.
Why was this product recalled?
IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 4, 2018. Severity: Moderate. Recall number: Z-2284-2018.