MAGNETOM Cima.X (DE). Model Number: 11647158.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number: 11647158. UDI Numbers: (01)04056869975221(21)213029, (01)04056869975221(21)213006, (01)04056869975221(21)213062, (01)04056869975221(21)213043, (01)04056869975221(21)213041, (01)04056869975221(21)213034, (01)04056869975221(21)213035, (01)04056869975221(21)213028, (01)04056869975221(21)213031, (01)04056869975221(21)213018, (01)04056869975221(21)213061, (01)04056869975221(21)213005, (01)04056869975221(21)213021, (01)04056869975221(21)213022, (01)04056869975221(21)213056, (01)04056869975221(21)213030, (01)04056869975221(21)213039, (01)04056869975221(21)213025, (01)04056869975221(21)213063, (01)04056869975221(21)213057, (01)04056869975221(21)213026, (01)04056869975221(21)213020. Serial Numbers: 213029, 213006, 213062, 213043, 213041, 213034, 213035, 213028, 213031, 213018, 213061, 213005, 213021, 213022, 213056, 213030, 213039, 213025, 213063, 213057, 213026, 213020.
- 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:
MAGNETOM Cima.X (DE). Model Number: 11647158.
Product Codes/Lot Numbers:
Model Number: 11647158. UDI Numbers: (01)04056869975221(21)213029, (01)04056869975221(21)213006, (01)04056869975221(21)213062, (01)04056869975221(21)213043, (01)04056869975221(21)213041, (01)04056869975221(21)213034, (01)04056869975221(21)213035, (01)04056869975221(21)213028, (01)04056869975221(21)213031, (01)04056869975221(21)213018, (01)04056869975221(21)213061, (01)04056869975221(21)213005, (01)04056869975221(21)213021, (01)04056869975221(21)213022, (01)04056869975221(21)213056, (01)04056869975221(21)213030, (01)04056869975221(21)213039, (01)04056869975221(21)213025, (01)04056869975221(21)213063, (01)04056869975221(21)213057, (01)04056869975221(21)213026, (01)04056869975221(21)213020. Serial Numbers: 213029, 213006, 213062, 213043, 213041, 213034, 213035, 213028, 213031, 213018, 213061, 213005, 213021, 213022, 213056, 213030, 213039, 213025, 213063, 213057, 213026, 213020.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2656-2025
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