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

Recall Z-0422-2023 — Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)

U.S. FDA — Device Enforcement · United States · 2022-11-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0422-2023
Date of alert
2022-11-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Getinge Usa Sales Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
7325710010457
Reported risk: The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to provide the expected run time in the event of a mains power failure. This could require the clinician to use manual emergency ventilation of another ventilator is not available and the backup battery is exhausted.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.