Events

Recall of Device Recall Evita 4 Continuous Ventilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Draeger 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
    26388
  • Event Risk Class
    Class 2
  • Event Number
    Z-0954-03
  • Event Initiated Date
    2003-05-07
  • Event Date Posted
    2003-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-01-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27601
  • 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, Continuous, Facility Use - Product Code CBK
  • Reason
    Software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.
  • Action
    The recalling firm issued recall letters to the accounts dated 5/7/03.

Device

Device Recall Evita 4 Continuous Ventilator
  • Model / Serial
    Catalog numbers 4116640 and 8412980
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped nationwide to distributor, hospitals and a physician. The product was also shipped to medical facilities and universities in Canada.
  • Product Description
    Evita 4 Continuous Ventilator
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

Draeger Medical, Inc.
  • Manufacturer Address
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969
  • Source
    USFDA