Z-0600-2020 Class II Terminated

Recalled by CooperSurgical, Inc. — Trumbull, CT

Recall Details

Product Type
Devices
Report Date
December 11, 2019
Initiation Date
October 16, 2019
Termination Date
June 30, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product 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.

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