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

Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia. — recall Z-0081-2025

U.S. FDA — Device Enforcement · United States · 2024-07-12 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0081-2025
Date of alert
2024-07-12
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Datex-Ohmeda, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00840682102292
Reported risk: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.