CooperSurgical, Inc. recalls Quantam 2000 Electrosurgical Generator, Part number 909075-05W.

Recall date

October 16, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0602-2020

FDA classification

Class II

Brand / firm

CooperSurgical, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Quantam 2000 Electrosurgical Generator, Part number 909075-05W.