Devices

Device Recall ProteusONE

Model / Serial
SBF.101 (EU), SBF.105 (US)
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) to: MI only and country of: France.
Product Description
Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 || The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Manufacturer
Ion Beam Applications S.A.
1 Event
- Recall of Device Recall ProteusONE

Manufacturer

Ion Beam Applications S.A.

Manufacturer Address
Ion Beam Applications S.A., Chemin du Cyclotron, 3, Louvain La Neuve Belgium
Manufacturer Parent Company (2017)
Ion Beam Applications SA
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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