🔍 RecallPedia

Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.

Class I - Dangerous
🏥 Medical Devices Recalled: September 4, 2018 Alpha Omega Engineering Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial numbers: 113, 115, 116, 118, 123, 121, 125, 129, 130, 137, 138, 141, 140, 146, 149, 147, 156/04, 159/04, 163/04, 161/04, 167, 175/06, 176/06, 177/06, 180/06, 182/06, 185/06, 188/06, and 189.
  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:
Alpha Omega Engineering
Reason for Recall:
If cables are improperly connected, current may reach high charge density, causing tissue harm.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.

Product Codes/Lot Numbers:

Serial numbers: 113, 115, 116, 118, 123, 121, 125, 129, 130, 137, 138, 141, 140, 146, 149, 147, 156/04, 159/04, 163/04, 161/04, 167, 175/06, 176/06, 177/06, 180/06, 182/06, 185/06, 188/06, and 189.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1216-2019