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

Recall Z-0109-2022 — Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400

U.S. FDA — Device Enforcement · United States · 2021-09-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0109-2022
Date of alert
2021-09-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Draeger Medical, Inc.
Product category
device
Product type
Devices
Reported risk: Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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