Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: (01)00884838099722(21) Serial Numbers: 41017 41024 41025 41041 41047 41051 41080 41089 41130 41143 41144 41189 41196 41226 41235 41286 41287 41344 41367 41413 41432 41433 41497 41520 70093 70099 70202 70260 70589 70996 81073 84370
- 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 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116
Product Codes/Lot Numbers:
UDI-DI: (01)00884838099722(21) Serial Numbers: 41017 41024 41025 41041 41047 41051 41080 41089 41130 41143 41144 41189 41196 41226 41235 41286 41287 41344 41367 41413 41432 41433 41497 41520 70093 70099 70202 70260 70589 70996 81073 84370
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1829-2024
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