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U.S. Department of Health and Human Services

Class 1 Device Recall Inspiration Ventilator System

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  Class 1 Device Recall Inspiration Ventilator System see related information
Date Initiated by Firm October 13, 2015
Date Posted November 19, 2015
Recall Status1 Terminated 3 on June 22, 2017
Recall Number Z-0230-2016
Recall Event ID 72491
510(K)Number K130178  
Product Classification Ventilator, continuous, facility use - Product Code CBK
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.
Code Information All models manufactured prior to 2015 are affected
Recalling Firm/
Manufacturer		 Event Medical LTD
60 Empire Dr
Lake Forest CA 92630-2244
For Additional Information Contact
949-900-1917 Ext. 232
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
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.
Quantity in Commerce 6441 units total (251 units in US)
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = EVENT MEDICAL LTD
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