Inspiration Ventilator System recall
Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in…
Why was Inspiration Ventilator System recalled?
A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All models manufactured prior to 2015 are affected
- 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…
- Recalling firm
- Event Medical LTD
- Quantity
- 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
- Recall date
- November 25, 2015
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)