Events

Recall of Device Recall AVEA Ventilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Viasys Respiratory Care, Inc.dba Bird Products.

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
    46215
  • Event Risk Class
    Class 2
  • Event Number
    Z-0985-2008
  • Event Initiated Date
    2007-12-17
  • Event Date Posted
    2008-05-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67394
  • 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
    Continuous Ventilator - Product Code CBK
  • Reason
    Alarm failure -- there is a potential of alarms not being activated subsequent to specific electronic faults that may cause inop condition.
  • Action
    On December 18, 2007, a product notification letter was mailed to all customers in the United States via overnight carrier (registed mail) and a product notification letter was mailed to all international customers via Federal Express. The recall letter informed the customers of the problem and also inform them that a Cardinal Health (Viasys) service representative will be contacting them immediately to arrange & service their ventilator. For futher information please contack Andrea von Muller at 760-778-7323.

Device

Device Recall AVEA Ventilator
  • Model / Serial
    Catalog numbers: 17311-00; Serial numbers: AHV03000, AHV03001, AHV03004, AHV03005
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AL, CA, MA, NM, NV, and NY and country of Italy.
  • Product Description
    VIASYS AVEA Ventilator, Catalog numbers: 17311-00 (USA Standard Version)
  • Manufacturer
    Viasys Respiratory Care, Inc.dba Bird Products

Manufacturer

Viasys Respiratory Care, Inc.dba Bird Products
  • Manufacturer Address
    Viasys Respiratory Care, Inc.dba Bird Products, 1100 Bird Center Dr, Palm Springs CA 92262-8000
  • Source
    USFDA