FDA Medical Device Recalls (openFDA)
Ion Beam Applications S.A.: Proteus 235 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.
- Recall number
- Z-2715-2020
- Recalling firm
- Ion Beam Applications S.A.
- Product
- Proteus 235 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.
- Status
- Terminated
- Initiated
- 2020-07-17
- Posted
- not on file
- Terminated
- 2021-08-30
- Reason
- IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
- Root cause
- Software design
- Action
- An Urgent Medical Device Correction notification will be communicated to all impacted IBA customers (users of the device), starting July 23, 2020. This letter instructs the customer: If this situation were to occur, it is recommended to complete the aborted treatment in Standalone Mode (please refer to the steps described in annex I and to the part Using adaPTdeliver in Standalone Mode of the Proton Therapy System Clinical Users Guide). IBA will modify the software to remove conditions that make impossible to load the plan to complete the aborted treatment. The solution will be deployed on your site by June 30, 2022.
- Quantity
- 2 Units
- Distribution
- US: VA OUS: Belgium
- Lot, serial or model codes
- Serial Number: Manufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019
- 510(k) numbers
- ["K163500"]
- 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