FDA Medical Device Recalls (openFDA)
Ion Beam Applications S.A.: Proteus 235, Uniform and Pencil Beam Scanning 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-0934-2018
- Recalling firm
- Ion Beam Applications S.A.
- Product
- Proteus 235, Uniform and Pencil Beam Scanning 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
- 2017-12-05
- Posted
- not on file
- Terminated
- 2019-03-29
- Reason
- An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate.
- Root cause
- Device Design
- Action
- Ion Beam Applications (IBA) sent an Urgent Field Safety Notice dated December 5, 2017, to customers informing them of the issue and request that all users verify that the accessory is correctly inserted in snout 300x400 with both rails in the guide. A solution to this issue including a hardware modification will be deployed on or before March 31, 2018. For further questions, please call (215) 972-7985.
- Quantity
- 14
- Distribution
- US Distribution to the states of : MA, FL, VA, PA, OK, TN
- Lot, serial or model codes
- PAT.000 (US), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.110 (US), SAT.119 (US).
- 510(k) numbers
- ["K060695"]
- 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