Home / Recalls / Event Medical LTD / Z-0230-2016

Z-0230-2016 Class I Terminated

Recalled by Event Medical LTD — Lake Forest, CA

Recall Details

Product Type: Devices
Report Date: November 25, 2015
Initiation Date: October 13, 2015
Termination Date: June 22, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6441 units total (251 units in US)

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

All models manufactured prior to 2015 are affected