Reported Jun 13, 2018 · Terminated

12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or…

Ion Beam Applications S.A.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ion Beam Applications S.A. · Chemin du Cyclotron, 3 · Louvain La Neuve, N/A · N/A

Is this the product you have?

  • 12C (AdaPTinsight)
  • Affected componentAdaPTinsight
  • software Product Usage12C 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
Lot codes and dates
  • Affected units
    • SAT.123
    • SAT.126
    • PAT.115
    • SAT.122 and SBF.101
Amount recalled
5 units (12C)

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 9, 2019 · Data as of Sep 19, 4:46 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.