PlainRecalls
FDA Devices Moderate Class II Terminated

Quantam 2000 Electrosurgical Generator, Part number 909075.

Reported: December 11, 2019 Initiated: October 16, 2019 #Z-0600-2020

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.

Details

Recalling Firm
CooperSurgical, Inc.
Units Affected
105
Distribution
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.
Location
Trumbull, CT

Frequently Asked Questions

What product was recalled?
Quantam 2000 Electrosurgical Generator, Part number 909075.. Recalled by CooperSurgical, Inc.. Units affected: 105.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 11, 2019. Severity: Moderate. Recall number: Z-0600-2020.