FDA Medical Device Recalls (openFDA)
Ion Beam Applications S.A.: Proteus 235, Proton Therapy System
- Recall number
- Z-1830-2017
- Recalling firm
- Ion Beam Applications S.A.
- Product
- Proteus 235, Proton Therapy System
- Status
- Terminated
- Initiated
- 2017-03-21
- Posted
- not on file
- Terminated
- 2018-09-19
- Reason
- In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
- Root cause
- Software design
- Action
- A Field Safety Notice was mailed to the customer affected by the issue on 03/21/2017. The Notice informed the user when resuming from a partial irradiation, to ensure that the correct delivered dose has been selected in the partial report dialog box before proceeding with irradiation.
- Quantity
- 2 worldwide, 1 in U.S.
- Distribution
- Distribution in US (to Louisiana), and France.
- Lot, serial or model codes
- Serial Number: SAT.123 (US), and SBF.101 (EU). Versions PTS-9.3.1.2 and PTS-9.4.0
- 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