🔍 RecallPedia

Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782103

Class I - Dangerous
🏥 Medical Devices Recalled: September 3, 2024 Philips North America Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: (01)00884838098299(21) Serial Numbers: 85625 85626 85628 85630 85633 85637 85638 85641 85642 85646 85650 85652 85653 85654 85656 85657 85658 85659 85660 85662 85664 85666 85667 85668 85672 85674 85682 85683 85686 85692 85696 85701 85713
  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:
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782103

Product Codes/Lot Numbers:

UDI-DI: (01)00884838098299(21) Serial Numbers: 85625 85626 85628 85630 85633 85637 85638 85641 85642 85646 85650 85652 85653 85654 85656 85657 85658 85659 85660 85662 85664 85666 85667 85668 85672 85674 85682 85683 85686 85692 85696 85701 85713

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-3195-2024

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