BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0230-2016 · Initiated October 13, 2015

    Recall

    Recall Number
    Z-0230-2016
    Event Number
    72491
    Firm
    Event Medical LTD
    FEI Number
    3006135941
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 13, 2015
    Posted
    November 19, 2015
    Terminated
    June 22, 2017
    Address
    60 Empire Dr, Lake Forest, CA, 92630-2244

    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.

    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.

    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

    Quantity

    6441 units total (251 units in US)