Z-2109-2018Class II

12C (AdaPTinsight) Affected component: AdaPTinsight software

Name: Z-2109-2018 12C (AdaPTinsight) Affected component: AdaPTinsight software
Creator: Ion Beam Applications S.A.
Published: 2016-10-28
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2016-10-28 / Terminated / root cause: software

FDA source

Ion Beam Applications S.A. began a recall of 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for... on 2016-10-28. FDA classified it as Class II and gives the reason as "IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2109-2018
Classification: Class II
Status: Terminated
Initiated: 2016-10-28
Posted: 2018-06-07
Terminated: 2019-08-09
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.
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: Affected units: SAT.123, SAT.126, PAT.115, SAT.122 and SBF.101

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2109-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2109-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07

Product code LHN

K132847Class III2cIon Beam Applications S.A. / cleared 2013-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)