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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Affected units: SAT.123, SAT.126, PAT.115, SAT.122 and SBF.101
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Ion Beam Applications S.A.
- Reason for Recall:
- IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 Codes/Lot Numbers:
Affected units: SAT.123, SAT.126, PAT.115, SAT.122 and SBF.101
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2109-2018
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