Events

Recall of Esprit Ventilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Respironics California 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
    48997
  • Event Risk Class
    Class 2
  • Event Number
    Z-2084-2013
  • Event Initiated Date
    2007-10-29
  • Event Date Posted
    2013-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72498
  • 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
    The power to the esprit display's backlight is interrupted, causing the gui to flicker or go dark and making the display unreadable.
  • Action
    A Medical Device Field Correction letter dated 10/26/2007 was sent to all customers who received the Esprit Ventilator. The recall letter informed the customers of the problems identified and the actions to be taken. Customers with questions are instructed to contact Respironics' Customer Service Dept. at (800) 345-6443, select Option#5, then select Option #4.

Device

Esprit Ventilator
  • Model / Serial
    Model Number: V1000
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide and Worldwide to Algeria, Argentina, Australia, Bangladesh, Brazil, Cambodia, Canada, Chile, Colombia, Ecuador, Egypt, France, Germany, Guatemala, Hong Kong, India, Italy, Japan, Libya, Malaysia, Mexico, Pakistan, Peru, Philippines, Puerto Rico, Russia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.
  • Product Description
    Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
  • Manufacturer
    Respironics California Inc

Manufacturer

Respironics California Inc
  • Manufacturer Address
    Respironics California Inc, 2271 Cosmos Ct, Carlsbad CA 92011-1517
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA