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

Recall Z-0959-2023 — Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400

U.S. FDA — Device Enforcement · United States · 2022-12-22 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0959-2023
Date of alert
2022-12-22
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Getinge Usa Sales Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
7325710001349
Reported risk: Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.
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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