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Ion Beam Applications S.A. FDA Recalls
11 recalls on file across devices, 0 of them Class I and 10 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| IBA Proton Therapy System - PROTEUS 235Class IIFeb 3, 2026It was identified that eh Universal Beam Triggering Interfac |
| IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients witClass IIJul 10, 2024Temporary deactivation of collision detection for Forte Robo |
| IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versionsClass IIJul 8, 2024Safety Parameters Verification Mechanisms can be deactivated |
| IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients wiClass IIMay 10, 2024Irradiation is not interrupted when some C230 Accelerator Co |
| IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.Class IIMar 4, 2024There is a risk of mistreatment as irradiation is not preven |
| IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured withClass IISep 18, 2023The patient positioning system can perform motions in unexpe |
| Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tuClass IIApr 20, 2022First layer of Uniform Scanning treatment fields is sometime |
| ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tClass IIFeb 15, 2022When resuming from a beam pause, the Proton Therapy System d |
| Proteus 235; Version: PTS-8 versions before PTS-8.7.2Class IINov 29, 2021Proton Therapy System (PTS) software can be started in the |
| Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and otherClass IIJun 14, 2021Users may be misled by the popup message displayed by the Pr |
| Proteus 235-Proton Therapy SystemClass IIMay 26, 2021if the user forgets to select the trigger input manually wh |