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

Recall Z-1787-2012 — GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.

U.S. FDA — Device Enforcement · United States · 2012-04-10 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1787-2012
Date of alert
2012-04-10
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Reported risk: GE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your Aestiva 7900 Anesthesia Device. This Potential for two (2) vaporizers delivering agent at the same time. This could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent. This m
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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