🔍 RecallPedia

Hitachi Echelon Oval MRI System

Class I - Dangerous
🏥 Medical Devices Recalled: April 16, 2015 Hitachi Medical Systems America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y013, Y014, Y015, Y016, Y101, Y102, Y103, Y104, Y105, Y106, Y107, Y108, Y951
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Hitachi Medical Systems America Inc
Reason for Recall:
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Hitachi Echelon Oval MRI System

Product Codes/Lot Numbers:

Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y013, Y014, Y015, Y016, Y101, Y102, Y103, Y104, Y105, Y106, Y107, Y108, Y951

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1541-2017

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