Z-0954-03

Evita 4 Continuous Ventilator

Name: Z-0954-03 Evita 4 Continuous Ventilator
Creator: Draeger Medical, Inc.
Published: 2003-05-07
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2003-05-07 / Terminated / root cause: software

FDA source

Draeger Medical, Inc. began a recall of Evita 4 Continuous Ventilator on 2003-05-07. The reason FDA records is "software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm". 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-0954-03
Status: Terminated
Initiated: 2003-05-07
Posted: 2003-06-27
Terminated: 2006-01-20
Recalling firm: Draeger, Inc.
Product: Evita 4 Continuous Ventilator
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.
Root cause tag: software
FDA root cause: Other
Action: The recalling firm issued recall letters to the accounts dated 5/7/03.
Quantity in commerce: 806 units
Distribution: The product was shipped nationwide to distributor, hospitals and a physician. The product was also shipped to medical facilities and universities in Canada.
Product codes and lots: Catalog numbers 4116640 and 8412980

Product code CBK

K010093Class IINon-Invasive Ventilation Niv Option, Model 84 14 474Drager Medizintechnik GmbH / cleared 2001-06-14

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)