Z-1690-2021Class II

Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 -

Name: Z-1690-2021 Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 -
Creator: Draeger Medical, Inc.
Published: 2021-04-16
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2021-04-16 / Terminated / root cause: software

FDA source

Draeger Medical, Inc. began a recall of Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory... on 2021-04-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1690-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-16
Posted: 2021-05-28
Terminated: 2024-02-06
Recalling firm: Draeger, Inc.
Product: 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.
Product code: CBK Ventilator, Continuous, Facility Use
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
Root cause tag: software
FDA root cause: Software design
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:
Quantity in commerce: 34 units
Distribution: US Nationwide distribution in the states of PA, TX, MD, FL, TX, WA, MS, NY.
Product codes and lots: All lots/serial numbers manufactured from 1/1/2019-3/31201

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1690-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1690-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-05-28
Z-1691-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-05-28
Z-1692-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-05-28
Z-1693-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-05-28

Product code CBK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)