Quantam 2000 Electrosurgical Generator, Part number 909075-05.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial numbers: 2015120001-2015120030 2016030001-2016030030 2016040001-2016040018 2016050001-2016050030 2016060001-2016060020 2016070001-2016070040 2016080001-2016080006 2016090001-2016090016 2016110001-2016110008 2016120001-2016120006 2017010001-2017010008 2017020001-2017020009 2017030001-2017030011 2017040001-2017040008 2017060001-2017060015 2017080002 2017080006 2017080010
  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:
CooperSurgical, Inc.
Reason for Recall:
Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for activation.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Quantam 2000 Electrosurgical Generator, Part number 909075-05.

Product Codes/Lot Numbers:

Serial numbers: 2015120001-2015120030 2016030001-2016030030 2016040001-2016040018 2016050001-2016050030 2016060001-2016060020 2016070001-2016070040 2016080001-2016080006 2016090001-2016090016 2016110001-2016110008 2016120001-2016120006 2017010001-2017010008 2017020001-2017020009 2017030001-2017030011 2017040001-2017040008 2017060001-2017060015 2017080002 2017080006 2017080010

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0601-2020

Related Recalls