Food, drugs, devices › CooperSurgical, Inc.
Device recall: Quantam 2000 Electrosurgical Generator, Part number 909075.
FDA enforcement event 84132 is a device recall by CooperSurgical, Inc. of Trumbull, CT, initiated 16 Oct 2019 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 30 Jun 2020. Initiation: voluntary: firm initiated. CooperSurgical, Inc. has 57 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
CooperSurgical, Inc., Trumbull, CT.
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
"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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0600-2020 | Quantam 2000 Electrosurgical Generator, Part number 909075. | 105 | Class II | Terminated | 11 Dec 2019 |
| Z-0601-2020 | Quantam 2000 Electrosurgical Generator, Part number 909075-05. | 110 | Class II | Terminated | 11 Dec 2019 |
| Z-0602-2020 | Quantam 2000 Electrosurgical Generator, Part number 909075-05W. | 4 | Class II | Terminated | 11 Dec 2019 |
Context
Other enforcement events for CooperSurgical, Inc.
All 57 events for CooperSurgical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Jun 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.