Ion Beam Applications S.A.: Medical Device Recall in 2018 - (Recall #: Z-2284-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 11, 2016

Date Posted: July 4, 2018

Recall Number: Z-2284-2018

Event ID: 80217

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.

Status: Terminated

Product Quantity: 2

Code Information:

PAT.003 and PAT.006

Distribution Pattern:

Units were distributed to Korea and Jacksonville, FL.

Voluntary or Mandated: