Event Medical LTD recalls Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by h

Recalled November 25, 2015 · FDA recall Z-0230-2016 · Event Medical

Hazard

A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming. · FDA Class I

Units

6441 units total (251 units in US)

Sold at

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

Description

A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming.

Product

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(s)

Event Medical LTD

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →