FDA Medical Device Recalls (openFDA)
Ion Beam Applications S.A.: Proteus 235, graphite block 8
- Recall number
- Z-0930-2018
- Recalling firm
- Ion Beam Applications S.A.
- Product
- Proteus 235, graphite block 8
- Status
- Terminated
- Initiated
- 2017-10-17
- Posted
- not on file
- Terminated
- 2019-03-29
- Reason
- IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader
- Root cause
- Component design/selection
- Action
- On July 17, 2017 An Urgent Field Safety Notice was issued to customers with the following user action: In case a patient treatment plan requires the use of the block 8, it is recommended to perform a full range verification during the patient treatment plan QA check. After the replacement of the graphite block 8, it is recommended to verify there is no effect on the Bragg peak.
- Quantity
- 3
- Distribution
- WA
- Lot, serial or model codes
- PAT.115, SAT.116
- 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