🔍 RecallPedia

Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.

Class I - Dangerous
🏥 Medical Devices Recalled: March 15, 2019 GE Healthcare Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Number 5503558; System ID Number 0850060757; Serial Number B3-16-015
  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:
There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.

Product Codes/Lot Numbers:

Model Number 5503558; System ID Number 0850060757; Serial Number B3-16-015

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1199-2019

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