Z-0982-2008

VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive Version)

Name: Z-0982-2008 VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive Version)
Creator: Viasys Respiratory Care, Inc.dba Bird Products
Published: 2007-12-17
License: https://open.fda.gov/license/

ZOLL Palm Springs / initiated 2007-12-17 / Terminated / root cause: design

FDA source

Viasys Respiratory Care, Inc.dba Bird Products began a recall of VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive Version) on 2007-12-17. The reason FDA records is "Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0982-2008
Status: Terminated
Initiated: 2007-12-17
Posted: 2008-05-14
Terminated: 2008-05-13
Recalling firm: ZOLL Palm Springs
Product: VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive Version)
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.
Root cause tag: design
FDA root cause: Component design/selection
Action: On December 18, 2007, a product notification letter was mailed to all customers in the United States via overnight carrier (registed mail) and a product notification letter was mailed to all international customers via Federal Express. The recall letter informed the customers of the problem and also inform them that a Cardinal Health (Viasys) service representative will be contacting them immediately to arrange & service their ventilator. For futher information please contack Andrea von Muller at 760-778-7323.
Quantity in commerce: 2
Distribution: Worldwide Distribution --- USA including states of AL, CA, MA, NM, NV, and NY and country of Italy.
Product codes and lots: Catalog numbers: 17210-00; Serial numbers: AGV02302, AEV01757

Product code CBK

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)