Reported Nov 25, 2015 · Terminated

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

Event Medical Ltd.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Event Medical LTD · 60 Empire Dr · Lake Forest, CA · 92630-2244

Is this the product you have?

  • 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.
Lot codes and dates
  • All models manufactured prior to 2015 are affected
Amount recalled
6441 units total (251 units in US)

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 22, 2017 · Data as of Sep 19, 5:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.