Recall Z-0601-2020— CooperSurgical, Inc.

Name: FDA recall Z-0601-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-16

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2019-10-16, terminated 2020-06-30. It names one FDA 510(k) clearance: K963653. Product: Quantam 2000 Electrosurgical Generator, Part number 909075-05.. Reason: 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..

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-10-16
Terminated: 2020-06-30
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K963653 — WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEMWallach Surgical Devices, Inc.·cleared 1997-06-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Quantam 2000 Electrosurgical Generator, Part number 909075-05.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.