MRI system: Vantage Elan, Model: MRT-2020
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 04987670101632. Serial Number: S1F2052753
- 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:
- Canon Medical System, USA, INC.
- Reason for Recall:
- For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
MRI system: Vantage Elan, Model: MRT-2020
Product Codes/Lot Numbers:
UDI-DI: 04987670101632. Serial Number: S1F2052753
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1249-2024
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