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Terminated

Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.

FDA Recall Z-1690-2021 · Posted None

Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2021-04-16
Date Terminated2024-02-06
Product Quantity34 units

Reason for Recall

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

Firm Action

In April, 2021, Draeger issued an Urgent Medical Device Correction notice to customer via letter notifying them that Draeger became aware of three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800:

Root Cause

Software design

Distribution Pattern

US Nationwide distribution in the states of PA, TX, MD, FL, TX, WA, MS, NY.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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