🔍 RecallPedia

Ingenia Elition X-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: 781358

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: US: 45245 (01)00884838088115(21)45245; 45247 (01)00884838088115(21)45247; 45261 (01)00884838088115(21)45261; 45263 (01)00884838088115(21)45263; 45264 (01)00884838088115(21)45264; 45269 (01)00884838088115(21)45269; OUS: 45215 (01)00884838088115; 45284 (01)00884838088115; 45253 (01)00884838088115; 45313 (01)00884838088115; 45265 (01)00884838088115; 45297 (01)00884838088115; 45218 (01)00884838088115; 45272 (01)00884838088115; 45281 (01)00884838088115; 45231 (01)00884838088115; 45278 (01)00884838088115; 45279 (01)00884838088115; 45245 (01)00884838088115; 45247 (01)00884838088115;
  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 X-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: 781358

Product Codes/Lot Numbers:

S/N and UDI: US: 45245 (01)00884838088115(21)45245; 45247 (01)00884838088115(21)45247; 45261 (01)00884838088115(21)45261; 45263 (01)00884838088115(21)45263; 45264 (01)00884838088115(21)45264; 45269 (01)00884838088115(21)45269; OUS: 45215 (01)00884838088115; 45284 (01)00884838088115; 45253 (01)00884838088115; 45313 (01)00884838088115; 45265 (01)00884838088115; 45297 (01)00884838088115; 45218 (01)00884838088115; 45272 (01)00884838088115; 45281 (01)00884838088115; 45231 (01)00884838088115; 45278 (01)00884838088115; 45279 (01)00884838088115; 45245 (01)00884838088115; 45247 (01)00884838088115;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2344-2021

Related Recalls