Z-0230-2016Class I

Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be...

Name: Z-0230-2016 Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be...
Creator: Event Medical LTD
Published: 2015-10-13
License: https://open.fda.gov/license/

Event Medical Ltd / initiated 2015-10-13 / Terminated / root cause: design

FDA source

Event Medical LTD began a recall of 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... on 2015-10-13. FDA classified it as Class I and gives the reason as "A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0230-2016
Classification: Class I
Status: Terminated
Initiated: 2015-10-13
Posted: 2015-11-19
Terminated: 2017-06-22
Recalling firm: Event Medical Ltd
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.
Product code: CBK Ventilator, Continuous, Facility Use
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.
Root cause tag: design
FDA root cause: 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
Product codes and lots: All models manufactured prior to 2015 are affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0230-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0230-2016	Class I	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-19

Product code CBK

K130178Class IIInspiration Ventilator System 5I/7ieVent Medical, Ltd. / cleared 2013-10-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)