Events

Recall of Device Recall Viasys Vela Adult/Pediatric Lung 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
    37318
  • Event Risk Class
    Class 2
  • Event Number
    Z-0638-2007
  • Event Initiated Date
    2007-01-31
  • Event Date Posted
    2007-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50340
  • 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 - Product Code CBK
  • Reason
    The graphical user interface may become slow in its response and in some cases non-responsive. under some circumstances this situation may cause the ventilator to delay the annunciation of alarms.
  • Action
    On January 31, 2007, a product notification letter was mailed to all customers in the United States via overnight carrier (Federal Express). Consignees are informed in the notification letter that service calls are in process of being scheduled to update domestic consignees. On January 31, 2007, a product notification kit (including a product notification letter, download software, download instruction sheets and installation verification fax-back sheets) were mailed to all international customers via register mail. Consignees are informed in the notification letter that replacement software, replacement instructions, and installation verification forms are included in their recall package. Domestic Consignees will have product corrected by VIASYS service personnel. Self address postage paid envelopes will be provided with notifications to aid in effectiveness checks

Device

Device Recall Viasys Vela Adult/Pediatric Lung Ventilator
  • Model / Serial
    Lot numbers: AGT03640 thru AGT06049
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution ---USA and countries of Bangladesh, Bosnia, Brazil, China, Czech Republic, Ecuador, Estonia, Finland, France, Guatemala, Hong Kong, India, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Morocco, Netherlands, Portugal, Russian Federation, Taiwan, Thailand, Turkey & Vietnam.
  • Product Description
    VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.
  • 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