MEVION S250, used for proton radiation therapy.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Number: S250-0001
- 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:
- Mevion Medical Systems, Inc.
- Reason for Recall:
- Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
MEVION S250, used for proton radiation therapy.
Product Codes/Lot Numbers:
Serial Number: S250-0001
Distribution:
Distributed in: US, MO
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0588-2015
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