Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 professionals in hospitals or healthcare facilities and intra-hospital transport.

U.S. FDA — Device Enforcement · United States · 2015-10-13 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0230-2016
Date of alert
2015-10-13
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Event Medical LTD
Product category
device
Product type
Devices
Reported risk: A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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