OEC Flexiview 8800 Systems with 9-inch Image Intensifier

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 3228PU4, 6936PU9
  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 OEC Medical Systems, Inc
Reason for Recall:
Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

OEC Flexiview 8800 Systems with 9-inch Image Intensifier

Product Codes/Lot Numbers:

Serial Numbers: 3228PU4, 6936PU9

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2275-2023

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