Quantam 2000 Electrosurgical Generator, Part number 909075.

FDA Device Recall #Z-0600-2020 — Class II — October 16, 2019

Recall Summary

Recall Number Z-0600-2020
Classification Class II — Moderate risk
Date Initiated October 16, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm CooperSurgical, Inc.
Location Trumbull, CT
Product Type Devices
Quantity 105

Product Description

Quantam 2000 Electrosurgical Generator, Part number 909075.

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.

Distribution Pattern

US: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MA, ME, Ml, MT, ND, NJ, NV, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, & WV. International: China, Indonesia, South Africa, & Tanzania.

Lot / Code Information

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

Other Recalls from CooperSurgical, Inc.

Recall # Classification Product Date
Z-2136-2025 Class II Endosee System Convenience Kit. Model Number: E... Jun 11, 2025
Z-2135-2025 Class II HSG Procedure Tray. Model Number: 6050T. Th... Jun 11, 2025
Z-2137-2025 Class II Endosee System Convenience Kit with IV Tube. Mo... Jun 11, 2025
Z-0687-2025 Class II Brand Name: K-Systems Product Name: G73 Dry Ba... Nov 15, 2024
Z-0688-2025 Class II Brand Name: K-Systems Product Name: G85 Mini I... Nov 15, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.