FDA Medical Device Recalls (openFDA)
Ion Beam Applications S.A.: Proton therapy system -Proteus 235 aka Proteus Plus. 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-2097-2017
- Recalling firm
- Ion Beam Applications S.A.
- Product
- Proton therapy system -Proteus 235 aka Proteus Plus. 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
- 2017-04-10
- Posted
- 2017-05-03
- Terminated
- 2018-02-16
- Reason
- A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose.
- Root cause
- Software design
- Action
- Target date for software update June 30, 2017. A Field Safety Notice was issued on 4/10/2017 describing the problem and reminding users to follow guidance in the user's manual.
- Quantity
- 2
- Distribution
- FL
- Lot, serial or model codes
- Serial numbers: PAT.003, PAT.006
- 510(k) numbers
- ["K152224"]
- 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