Recall Z-0230-2016— Event Medical LTD

Name: FDA recall Z-0230-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-13

Class I · Terminated

Class I FDA medical device recall by Event Medical LTD, initiated 2015-10-13, terminated 2017-06-22. It names one FDA 510(k) clearance: K130178. 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.. Reason: A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming..

Recalling firm: Event Medical LTD
Classification: Class I
Status: Terminated
Initiated: 2015-10-13
Terminated: 2017-06-22
Firm location: Lake Forest, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K130178 — INSPIRATION VENTILATOR SYSTEM 5I/7IeVent Medical, Ltd.·cleared 2013-10-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.