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.
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510(K) Database | 510(K)s with Product Code = CBK
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