Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: (01)00884838099739(21) Serial Numbers: 42029 42217 42246 71044 71774 85146 85645 85663 85664 85668 85677 85680 85681 85685 85700 85704 85705 85706 85713
- 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:
- Philips North America Llc
- Reason for Recall:
- Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117
Product Codes/Lot Numbers:
UDI-DI: (01)00884838099739(21) Serial Numbers: 42029 42217 42246 71044 71774 85146 85645 85663 85664 85668 85677 85680 85681 85685 85700 85704 85705 85706 85713
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1830-2024
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