🔍 RecallPedia

Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781357 (OUS)

Class I - Dangerous
🏥 Medical Devices Recalled: July 30, 2021 Philips North America Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    S/N and UDI: 46083 (01)00884838088108; 46084 (01)00884838088108; 46086 (01)00884838088108; 46054 (01)00884838088108; 46058 (01)00884838088108; 46082 (01)00884838088108; 46061 (01)00884838088108;
  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:
Philips North America Llc
Reason for Recall:
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781357 (OUS)

Product Codes/Lot Numbers:

S/N and UDI: 46083 (01)00884838088108; 46084 (01)00884838088108; 46086 (01)00884838088108; 46054 (01)00884838088108; 46058 (01)00884838088108; 46082 (01)00884838088108; 46061 (01)00884838088108;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2347-2021

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