Z-2326-2008

Evita 4 Critical Care Ventilator. Continuous (Respirator)

Name: Z-2326-2008 Evita 4 Critical Care Ventilator. Continuous (Respirator)
Creator: Draeger Medical, Inc.
Published: 2008-07-02
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2008-07-02 / Terminated / root cause: manufacturing process

FDA source

Draeger Medical, Inc. began a recall of Evita 4 Critical Care Ventilator. Continuous (Respirator) on 2008-07-02. The reason FDA records is "audible power failure alarm was not enunciated at the required volume". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2326-2008
Status: Terminated
Initiated: 2008-07-02
Posted: 2008-09-20
Terminated: 2009-09-01
Recalling firm: Draeger, Inc.
Product: Evita 4 Critical Care Ventilator. Continuous (Respirator)
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: audible power failure alarm was not enunciated at the required volume
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued an URGENT MEDICAL DEVICE RECALL letter dated 7/2/08 informing the consignees of the problem and the need to have the circuit board replaced.
Quantity in commerce: 83 units
Distribution: The products were shipped to medical facilities in AZ, CA, CO, FL, GA, IL, KY, MA, MI, MS, NJ, NY, PA, TN, TX, UT and WA.
Product codes and lots: Catalog number 8411900. Products recalled had the CO2 Carrier Printed Circuit Board (PCB) part number 8306611 replaced between January 2005 and May 2008. The serial number for the affected CO2 Carrier PCBs have a prefix of ARW, ARX, or ARY.

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