🔍 RecallPedia

Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.

Class I - Dangerous
🏥 Medical Devices Recalled: January 3, 2024 Philips North America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    a. Model No. 781271; UDI-DI 00884838068452. b. Model No. 782105; UDI-DI 00884838098312. All units affected
  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
Reason for Recall:
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
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 CX. Model (REF) Numbers 781271, 782105.

Product Codes/Lot Numbers:

a. Model No. 781271; UDI-DI 00884838068452. b. Model No. 782105; UDI-DI 00884838098312. All units affected

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0951-2024

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