IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Class I - DangerousWhat Should You Do?
- Check if you have this product: PTS-10 versions, PTS-11 versions, and PTS-12 versions. UDI-DI: 05404013801138; Serial Numbers: SAT.123, SAT.126, SAT.133, SAT.140, SBF.105, SBF.113, SBF.128, SBF.135. All configurations.
- 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:
- There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Product Codes/Lot Numbers:
PTS-10 versions, PTS-11 versions, and PTS-12 versions. UDI-DI: 05404013801138; Serial Numbers: SAT.123, SAT.126, SAT.133, SAT.140, SBF.105, SBF.113, SBF.128, SBF.135. All configurations.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1603-2024
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