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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