🔍 RecallPedia

CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

Class I - Dangerous
🏥 Medical Devices Recalled: April 13, 2017 CardioTek BV Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    All EP-Tracer -FSCA-identifier (2017-04-06)
  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:
CardioTek BV
Reason for Recall:
Software bug which allows parameters to be changed unintentionally during use.
Classification:
Class I - Dangerous

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

Status:
completed

Product Information

Full Description:

CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

Product Codes/Lot Numbers:

All EP-Tracer -FSCA-identifier (2017-04-06)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2657-2017

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