DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
Class I - Dangerous 🏥 Medical Devices
Recalled: October 28, 2015 BC Group International Implants & Prosthetics
Nationwide
What Should You Do?
- Check if you have this product: SN: 73962222, 73962223, 73962224, 73962225, and 73962226
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- BC Group International Inc
- Reason for Recall:
- Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
Product Codes/Lot Numbers:
SN: 73962222, 73962223, 73962224, 73962225, and 73962226
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0457-2016