Wallach Quantum 2000 Electrosurgical System

• • Ongoing Z-0263-2022 FDA Class II ·initiated 29 Sep 2021

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• 4 recalls, same reason

  • Ongoing Z-0262-2022 FDA Class II ·initiated 29 Sep 2021
  • Ongoing Z-0259-2022 FDA Class II ·initiated 29 Sep 2021
  • Ongoing Z-0261-2022 FDA Class II ·initiated 29 Sep 2021
  • Ongoing Z-0260-2022 FDA Class II ·initiated 29 Sep 2021

  Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.

• 3 recalls, same reason

  • Terminated Z-0601-2020 FDA Class II ·initiated 16 Oct 2019
  • Terminated Z-0602-2020 FDA Class II ·initiated 16 Oct 2019
  • Terminated Z-0600-2020 FDA Class II ·initiated 16 Oct 2019

  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.

• • Terminated Z-2057-2019 FDA Class II ·initiated 18 Jun 2019

  The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal.

510(k) Number

K963653 ↗

FDA Product Code

HGI

Device Class

Class II

Regulation

21 CFR Part 884.4120

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• `the Inseminator' (Proposed)

  Class II

  FDA 510(k) K984306 Active Cleared 1 Mar 1999

• Wallach Cc/Brush

  Class II

  FDA 510(k) K896065 Active Cleared 4 Jan 1990

• Photostar V-8

  Class II

  FDA 510(k) K871681 Active Cleared 5 Aug 1987

• Wallach Ultra Freeze

  Class II

  FDA 510(k) K935010 Active Cleared 9 Feb 1994

• Clean Air

  Class II

  FDA 510(k) K943201 Active Cleared 28 Feb 1995

• Wallach Leap 100 Electro Surgery System

  Class II

  FDA 510(k) K921791 Active Cleared 4 May 1995

See all devices from Wallach Surgical Devices, Inc. →