Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X 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.
FDA Recall Z-0931-2018 · Posted None
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Recalling FirmIon Beam Applications S.A.
Recall StatusTerminated
Product CodeLHN
Date Initiated2017-10-19
Date Terminated2019-04-02
Product Quantity3
Reason for Recall
Range for the same energy could be different depending if the layer is
the first layer of the irradiation plan or not.
Firm Action
IBA sent an Urgent Field Safety Notice dated October 19, 2017 , issued to customers stating the following: IBA recommends performing a check to detect the consequence of this potential power supply regulation issue on a regular basis (IBA recommends Monthly), see Annex 1 for details.
IBA is developing a corrective action in order to reduce the hysteresis
effect and detect magnet current overshoot.
This solution will be deployed to all systems using JEMA analog power
supply. This solution will be validated and deployed by April 2018. For further questions, please call (215) 972-7985
Root Cause
Device Design
Distribution Pattern
US Distribution to the state of :FL
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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