FDA Medical Device Recalls (openFDA)
Ion Beam Applications S.A.: Proteus 235
- Recall number
- Z-1695-2017
- Recalling firm
- Ion Beam Applications S.A.
- Product
- Proteus 235
- Status
- Terminated
- Initiated
- 2017-03-09
- Posted
- 2017-03-23
- Terminated
- 2019-03-26
- Reason
- The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.
- Root cause
- Component design/selection
- Action
- A Field Safety Notice was mailed or handed to affected customers to inform them of the issue. The notice provides information on the issue, the risk for the patient and user and actions to be taken before starting gantry rotation. Corrective action developed by IBA are detailed.
- Quantity
- 8 worldwide, 4 in U.S.
- Distribution
- Distributed in MA, FL, VA, and TN. China, South Korea, France and Germany
- Lot, serial or model codes
- Serial numbers: PAT.000, PAT.001, PAT.003, PAT.006, PAT.108, PAT.111, SAT.119, SAT.120
- 510(k) numbers
- ["K101508"]
- 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