CLASS II Device recall · Reported 13 Jun 2018 · FDA Enforcement Report

12C (AdaPTinsight) component: AdaPTinsight recalled

Ion Beam Applications is recalling 12C (AdaPTinsight) component: AdaPTinsight, distributed nationwide in the US. The recall was initiated on 28 Oct 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAffected units: SAT.123, SAT.126, PAT.115, SAT.122 and SBF.101

Quantity recalled5 units (12C)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2109-2018
FDA event ID: 80219
Recalling firm: Ion Beam Applications, Louvain La Neuve, N/A
Classification: Class II
Status: Terminated
Recall initiated: 28 Oct 2016
FDA classified: 7 Jun 2018
Reported: 13 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

28 Oct 2016	Recall initiated by company
7 Jun 2018	Classified by FDA	+587 days
13 Jun 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Louisiana Texas

Questions about this recall

Is 12C (AdaPTinsight) component: AdaPTinsight recalled?

Yes. Ion Beam Applications recalled 12C (AdaPTinsight) component: AdaPTinsight on 28 Oct 2016. The recall is Class II and its status is Terminated. Recall number Z-2109-2018.

Why was it recalled?

IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.

Which lots are affected?

Affected units: SAT.123, SAT.126, PAT.115, SAT.122 and SBF.101

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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