Events

Recall of Device Recall Gryus SuperPulse

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

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
    27883
  • Event Risk Class
    Class 2
  • Event Number
    Z-0841-04
  • Event Initiated Date
    2003-12-05
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30685
  • 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 Radio Frequency Generator - Product Code GEI
  • Reason
    The generator may malfunction when used in close proximity to a monopolar generator.
  • Action
    On December 05, 2003, the firm sent recall notices to their affected customers by Certified Mail. The customers were notified that the firm would call them to arrange for pick up and correction of the device.

Device

Device Recall Gryus SuperPulse
  • Model / Serial
    Model 744000
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide throughout the United States.
  • Product Description
    Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications.
  • Manufacturer
    Gyrus Medical, Inc

Manufacturer

Gyrus Medical, Inc
  • Manufacturer Address
    Gyrus Medical, Inc, 6655 Wedgewood Road, Maple Grove MN 55311
  • Source
    USFDA