FDA Device recall Z-0230-2016
Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professional…
- FDA Device
- Class I
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class I recall of Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professional… by Event Medical, citing A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0230-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-10-13 |
| Published | 2015-11-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Event Medical |
| Distribution | US |
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.
Reason
A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming.
Identifiers
| code_info | All models manufactured prior to 2015 are affected |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0230-2016%22
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