12C (AdaPTinsight) Affected component: AdaPTinsight recall: Software Issue
12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for…
Why was 12C (AdaPTinsight) Affected component: AdaPTinsight recalled?
IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Affected units: SAT.123, SAT.126, PAT.115, SAT.122 and SBF.101
- Product
- 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for…
- Recalling firm
- Ion Beam Applications S.A.
- 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.
- Recall date
- June 13, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)