Events

Recall of Inogen One

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Inogen, 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
    32735
  • Event Risk Class
    Class 2
  • Event Number
    Z-1368-05
  • Event Initiated Date
    2005-08-01
  • Event Date Posted
    2005-08-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40717
  • 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
    Generator, Oxygen, Portable - Product Code CAW
  • Reason
    Firm plans to upgrade all units to correct situations that could lead to interuption in oxygen delivery.
  • Action
    Recall is scheduled to begin August 1st 2005 by letter to customers informing them that the units will be upgraded on a predetermined schedule. Firm estimates completion in 6 months.

Device

Inogen One
  • Model / Serial
    All codes.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Portable Oxygen Generator
  • Manufacturer
    Inogen, Inc

Manufacturer

Inogen, Inc
  • Manufacturer Address
    Inogen, Inc, 120 Cremona Dr Ste B, Goleta CA 93117-5564
  • Source
    USFDA