FDA Medical Device Recalls (openFDA)
Ion Beam Applications S.A.: Proteus 235 Proton Therapy System for cancer treatment.
- Recall number
- Z-0020-2015
- Recalling firm
- Ion Beam Applications S.A.
- Product
- Proteus 235 Proton Therapy System for cancer treatment.
- Status
- Terminated
- Initiated
- 2014-03-27
- Posted
- 2014-10-29
- Terminated
- 2014-12-10
- Reason
- While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a single voxel.
- Root cause
- Device Design
- Action
- A User Notice was sent to direct accounts in/about March/April 2014 to notify them of the issue and provide instructions to avoid the identified potential risk to patients.
- Quantity
- 8
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of PA, NJ, IL, WA, and TN, and the countries of Germany, Italy, and Czech Republic.
- Lot, serial or model codes
- PAT.107, PAT.109, PAT.112, PAT.113, PAT.114, PAT.115, PAT.116, PAT.119.
- 510(k) numbers
- ["K082416"]
- PMA numbers
- not on file
- Product code
- IYE
- 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