Class I — Event Medical LTD
| Recalling firm | eVent Medical |
|---|---|
| Registered facility | EVENT MEDICAL, LTD. (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming. |
| 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. |
| 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 … |
| Initiated | 2015-10-13 |
| Classified | 2015-11-19 |
| Terminated | 2017-06-22 |
| Recall number | Z-0230-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Event Medical LTD (Z-0230-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72491/
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