FDA-Device2023-11-22Class II
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
Ion Beam Applications S.A.
Hazard
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
Sold states
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.
Affected count
5 (US), 9 (OUS)
Manufactured in
Chemin Du Cyclotron 3, N/A, Ottignies-Louvain-La-Neuve, N/A, Belgium
Products
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0295-2024Don't want to check this manually?
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