FDA Medical Device Recalls (openFDA)
Ion Beam Applications S.A.: Proteus 235 Product Usage: 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-0698-2019
- Recalling firm
- Ion Beam Applications S.A.
- Product
- Proteus 235 Product Usage: 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
- 2018-12-12
- Posted
- not on file
- Terminated
- 2020-04-15
- Reason
- There is a risk of detachment of the Compact Gantry Rolling Floor.
- Root cause
- Device Design
- Action
- On December 12, 2018, the firm notified its customers of the recall via an Urgent Medical Device Correction letter. Customers were informed of the product issue. Customers were reminded that nobody should stand on the rolling floor when the gantry is rotating, as specified in the Clinical User Guide. The recalling firm stated they would take the following actions: Short-term action: IBA will replace the rod end bearings attaching the cGRF to the nozzle via a preventive maintenance on all ProteusONE sites. Long-term action: A new design of the anchoring system of the cGRF to the nozzle will be deployed on all impacted sites via an upgrade kit by end of October 2019. Customers with questions should contact Sylviane BERGER Vigilance@iba-group.com +32 10 203 787, or Helpdesk +32 2 507 20 81 (available 24/7)
- Quantity
- 7
- Distribution
- Worldwide Distribution - US Nationwide in the states of LA and MI. Foreign distribution to France, Japan, and UK.
- Lot, serial or model codes
- SAT.123, SBF.101, SBF.103, SBF.104, SBF.105, SBF.107, SBF.109
- 510(k) numbers
- ["K091629"]
- 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