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 hea…

Recall date

October 13, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0230-2016

FDA classification

Class I

Brand / firm

Event Medical LTD

Sold / distributed

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 Ind…

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.