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.123SAT.126PAT.115SAT.122 and SBF.101
- Affected units
- 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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