Events

Recall of Electrosurgical Unit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Conmed Electrosurgery.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    36253
  • Event Risk Class
    Class 2
  • Event Number
    Z-1508-06
  • Event Initiated Date
    2006-09-05
  • Event Date Posted
    2006-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48262
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrosurgical Unit - Product Code GEI
  • Reason
    Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy.
  • Action
    Domestic customers were notified by letter on 09/01/2006 and international accounts were notified by letter on 09/07/2006.

Device

Electrosurgical Unit
  • Model / Serial
    Serial Numbers: 06GGP 004, 06GGP 005, 06GGP 009, 06GGP 011, 06GGP 012, 06GGP 024, 06GGP 027 thru 030, 06GGP 057 thru 059, 06GGP 090 thru 092, 06GGP 131 thru 140, 06GGP 141 thru 144 ,,, 06FGP 022, 06FGP 023, 06FGP 029 thru 046, 06FGP 048 thru 056, 06FGP 062 thru 071, 06FGP 073 thru 079, 06FGP 090, 06FGP 106, 06FGP 107, 06FGP 110 thru 112 .
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Australia, Canada, France, Japan, Korea, New Zealand, Saudi Arabia, UK.
  • Product Description
    Conmed System 5000 Electrosurgical unit, REF 60-8005-SYS, 60-8015-SYS, 60-8018-SYS, 60-8005-001, 60-8005-003, Conmed Corporation.
  • Manufacturer
    Conmed Electrosurgery

Manufacturer

Conmed Electrosurgery
  • Manufacturer Address
    Conmed Electrosurgery, 7211 South Eagle Street, Centennial CO 80112
  • Source
    USFDA