🔍 RecallPedia

SIGNA Premier magnetic resonance scanner, model 5748519.

Class I - Dangerous
🏥 Medical Devices Recalled: June 24, 2022 GE Healthcare Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    SIGNA Premier GTINs: 00840682135269 and 00195278010797
  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:
GE Healthcare, LLC
Reason for Recall:
Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

SIGNA Premier magnetic resonance scanner, model 5748519.

Product Codes/Lot Numbers:

SIGNA Premier GTINs: 00840682135269 and 00195278010797

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1430-2022

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