Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Class I - DangerousWhat Should You Do?
- Check if you have this product: PAT.108 (US), PAT.110 (US), PAT.113 (US), PAT.114 (EU), SAT.119 (US).
- 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:
- Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes in the environment is not prevented even if some processes of the test environment (tcs) are still running. It may lead to situations where the system is using test processes without notifying the clinical user. If the versions of the processes are different between both environments, this could have an impact on patient treatments.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Product Codes/Lot Numbers:
PAT.108 (US), PAT.110 (US), PAT.113 (US), PAT.114 (EU), SAT.119 (US).
Distribution:
Distributed in: IN, VA, OK, NJ, TN
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0466-2022
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