🔍 RecallPedia

ST SENSE Breast Dx Coil

Class I - Dangerous
🏥 Medical Devices Recalled: November 4, 2024 Philips North America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    REF: 453530264791; UDI-DI: 00884838066823; Serial No. 55, 3, 9, 36, 40, 56, 35, 39, 80, 46, 29, 7, 28, 55, 47, 54.
  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:
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

ST SENSE Breast Dx Coil

Product Codes/Lot Numbers:

REF: 453530264791; UDI-DI: 00884838066823; Serial No. 55, 3, 9, 36, 40, 56, 35, 39, 80, 46, 29, 7, 28, 55, 47, 54.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0548-2025

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