Biograph mMR. Model Number: 10433372.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number: 10433372. UDI Number: (01)04056869006741(21)151032, (01)04056869006741(21)151057, (01)04056869006741(21)510535, (01)04056869006741(21)151034, (01)04056869006741(21)51003, (01)04056869006741(21)151021, (01)04056869006741(21)51055, (01)04056869006741(21)151013, (01)04056869006741(21)51064, (01)04056869006741(21)151044, (01)04056869006741(21)51038, (01)04056869245188(21)51006, (01)04056869006741(21)51030, (01)04056869006741(21)151004, (01)04056869006741(21)51022, (01)04056869006741(21)151049, (01)04056869006741(21)51007, (01)04056869006741(21)151045, (01)04056869006741(21)51032, (01)04056869006741(21)51057, (01)04056869006741(21)51015, (01)04056869006741(21)151025, (01)04056869006741(21)51048, (01)04056869006741(21)51062, (01)04056869006741(21)51010, (01)04056869006741(21)51051. Serial Numbers: 151032, 151057, 51053, 151034, 51003, 151021, 51055, 151013, 51064, 151044, 51038, 51006, 51030, 151004, 51022, 151049, 51007, 151045, 51032, 51057, 51015, 151025, 51048, 51062, 51010, 51051.
- 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:
- Siemens Medical Solutions USA, Inc
- Reason for Recall:
- There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Biograph mMR. Model Number: 10433372.
Product Codes/Lot Numbers:
Model Number: 10433372. UDI Number: (01)04056869006741(21)151032, (01)04056869006741(21)151057, (01)04056869006741(21)510535, (01)04056869006741(21)151034, (01)04056869006741(21)51003, (01)04056869006741(21)151021, (01)04056869006741(21)51055, (01)04056869006741(21)151013, (01)04056869006741(21)51064, (01)04056869006741(21)151044, (01)04056869006741(21)51038, (01)04056869245188(21)51006, (01)04056869006741(21)51030, (01)04056869006741(21)151004, (01)04056869006741(21)51022, (01)04056869006741(21)151049, (01)04056869006741(21)51007, (01)04056869006741(21)151045, (01)04056869006741(21)51032, (01)04056869006741(21)51057, (01)04056869006741(21)51015, (01)04056869006741(21)151025, (01)04056869006741(21)51048, (01)04056869006741(21)51062, (01)04056869006741(21)51010, (01)04056869006741(21)51051. Serial Numbers: 151032, 151057, 51053, 151034, 51003, 151021, 51055, 151013, 51064, 151044, 51038, 51006, 51030, 151004, 51022, 151049, 51007, 151045, 51032, 51057, 51015, 151025, 51048, 51062, 51010, 51051.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2654-2025
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