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

Recall Z-1692-2021 — Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.

U.S. FDA — Device Enforcement · United States · 2021-04-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1692-2021
Date of alert: 2021-04-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Draeger Medical, Inc.
Product category: device
Product type: Devices

Reported risk: Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-1692-2021 — Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.

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