🔍 RecallPedia

SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system

Class I - Dangerous
🏥 Medical Devices Recalled: July 6, 2015 Philips Electronics North America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    4522 131 5575x 4522 132 1985x 4522 132 7619x 4598 000 5187x 4598 000 5189x 4598 003 59051
  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 Electronics North America Corporation
Reason for Recall:
Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. The combined use of the Sense coil, high SAR level scanning and placement of the cables contrary to instructions for use can lead to patient burns.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system

Product Codes/Lot Numbers:

4522 131 5575x 4522 132 1985x 4522 132 7619x 4598 000 5187x 4598 000 5189x 4598 003 59051

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1024-2016

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