Events

Recall of Inspiration Ventilator System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Event Medical LTD.

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
    72491
  • Event Risk Class
    Class 1
  • Event Number
    Z-0230-2016
  • Event Initiated Date
    2015-10-13
  • Event Date Posted
    2015-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141260
  • 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
    A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming.
  • Action
    eVent Medical sent an Urgent Field Safety Notice dated October 12, 2015, to all affected customers on October 13, 2015, to inform them that eVent Medical is recalling Inspiration Ventilators i Series and LS 12.1 LCD because a component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming. The letter provides the customers with the problems identified and the actions to be taken. Customers with questions are instructed to call (949) 900-1917, x232.

Device

Inspiration Ventilator System
  • Model / Serial
    All models manufactured prior to 2015 are affected
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) and Internationally to: Algeria Argentina Australia Austria Bahrain Bangladesh Barbados Belarus Belgium Bolivia Canada Chile China Colombia Czech Rep Ecuador Egypt England Estonia Finland Germany Ghana Gibraltar Greece Guatemala Holland Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kenya Korea Kuwait Laos Latin America Lebanon Libya Lithuania Malaysia Mexico Morocco Nepal Netherlands New Zealand Norway Pakistan Palestine Panama Peru Philippines Poland Portugal Russia Saudi Arabia Serbia Singapore South Africa Spain Sri Lanka Sudan Switzerland Syria Taiwan Thailand Turkey UAE Ukraine USA Venezuela Vietnam Yemen Zimbabwe
  • Product Description
    Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
  • Manufacturer
    Event Medical LTD

Manufacturer

Event Medical LTD