Drug recall
Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be…
FDA recall event 72491 · Class I · Event Medical LTD
Key facts
| Event ID | 72491 |
|---|---|
| Recall numbers | Z-0230-2016 |
| Recalling firm | Event Medical LTD |
| Product type | Devices |
| Products | 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Oct 13, 2015 |
| Report date | Nov 25, 2015 |
| Termination date | Jun 22, 2017 |
| City | Lake Forest |
| State | CA |
| Country | United States |
| FEI number | 3006135941 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: