FDA Medical Device Recalls (openFDA)
Ion Beam Applications S.A.: 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system.
- Recall number
- Z-2109-2018
- Recalling firm
- Ion Beam Applications S.A.
- Product
- 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system.
- Status
- Terminated
- Initiated
- 2016-10-28
- Posted
- not on file
- Terminated
- 2019-08-09
- Reason
- IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.
- Root cause
- Software change control
- Action
- IBA mailed an Urgent Field Safety Notice to affected customers on 10/28/2016 to inform them of the issue. The issue will be solved in AdaPTinsights versions starting from Al 2.0. The solution was to be deployed on impacted IBA Proton Therapy sites by September 2017.
- Quantity
- 5 units (12C)
- Distribution
- Worldwide Distribution - US Nationwide in the states of LA, TX, Italy, Sweden and France. Each country's National Competent Authorities were notified of the firm's Field Safety Notice.
- Lot, serial or model codes
- Affected units: SAT.123, SAT.126, PAT.115, SAT.122 and SBF.101
- 510(k) numbers
- ["K132847"]
- 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