FDA recall Z-0295-2024

Ion Beam Applications S.A. · Class II · device

Product

IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.

Reason for recall

The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.

Distribution

Worldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan.

Key facts

Status
Ongoing
Initiation date
2023-09-18
Report date
2023-11-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ottignies-Louvain-La-Neuve, N/A, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0295-2024