Events

Recall of High Frequency Ventilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bunnell, 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
    33938
  • Event Risk Class
    Class 2
  • Event Number
    Z-0893-06
  • Event Initiated Date
    2005-04-04
  • Event Date Posted
    2006-05-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42764
  • 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
    Ventilator, High Frequency - Product Code LSZ
  • Reason
    Potential loss of air flow or change in cycling of the ventilator. valve drive regulator board may not function properly at elevated temperatures. the increase in temperature could cause a reduction of power, causing the solenoid in the valve to function sporadically.
  • Action
    Notified consignees by letter on 04/04/2005.

Device

High Frequency Ventilator
  • Model / Serial
    Serial numbers 2585 and below.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide, Military medical center, Canada, and Czech Republic
  • Product Description
    Life Pulse High Frequency Ventilator (HFV)
  • Manufacturer
    Bunnell, Inc.

Manufacturer

Bunnell, Inc.
  • Manufacturer Address
    Bunnell, Inc., 436 Lawndale Dr, Salt Lake City UT 84115-2917
  • Source
    USFDA