FDA Medical Device Recalls (openFDA)
Ion Beam Applications S.A.: 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.
- Recall number
- Z-0931-2018
- Recalling firm
- Ion Beam Applications S.A.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2017-10-19
- Posted
- not on file
- Terminated
- 2019-04-02
- Reason
- Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.
- Root cause
- Device Design
- 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
- Quantity
- 3
- Distribution
- US Distribution to the state of :FL
- Lot, serial or model codes
- PAT.003 (KR), PAT.006 (US)
- 510(k) numbers
- ["K082416"]
- PMA numbers
- not on file
- Product code
- LHN
- Firm FEI
- 3000256071
- Firm city
- Louvain La Neuve
- Firm state
- not on file
- Firm country
- Belgium
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28