Recall Z-0600-2020— CooperSurgical, Inc.

Name: FDA recall Z-0600-2020
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.. 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.

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.