FDA-Device2019-12-11Class II

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

CooperSurgical, Inc.
Hazard

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.

Sold states
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.
Affected count
4
Manufactured in
95 Corporate Dr, Trumbull, CT, United States
Products
Quantam 2000 Electrosurgical Generator, Part number 909075-05W.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0602-2020

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