Z-0638-2007

VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc

Name: Z-0638-2007 VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc
Creator: Viasys Respiratory Care, Inc.dba Bird Products
Published: 2007-01-31
License: https://open.fda.gov/license/

ZOLL Palm Springs / initiated 2007-01-31 / Terminated

FDA source

Viasys Respiratory Care, Inc.dba Bird Products began a recall of VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc on 2007-01-31. The reason FDA records is "The graphical user interface may become slow in its response and in some cases non-responsive. Under some circumstances this situation may cause the ventilator to delay the annunciation of alarms". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0638-2007
Status: Terminated
Initiated: 2007-01-31
Posted: 2007-03-20
Terminated: 2008-09-18
Recalling firm: ZOLL Palm Springs
Product: VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: The graphical user interface may become slow in its response and in some cases non-responsive. Under some circumstances this situation may cause the ventilator to delay the annunciation of alarms.
FDA root cause: Other
Action: On January 31, 2007, a product notification letter was mailed to all customers in the United States via overnight carrier (Federal Express). Consignees are informed in the notification letter that service calls are in process of being scheduled to update domestic consignees. On January 31, 2007, a product notification kit (including a product notification letter, download software, download instruction sheets and installation verification fax-back sheets) were mailed to all international customers via register mail. Consignees are informed in the notification letter that replacement software, replacement instructions, and installation verification forms are included in their recall package. Domestic Consignees will have product corrected by VIASYS service personnel. Self address postage paid envelopes will be provided with notifications to aid in effectiveness checks
Quantity in commerce: 878
Distribution: Worldwide Distribution ---USA and countries of Bangladesh, Bosnia, Brazil, China, Czech Republic, Ecuador, Estonia, Finland, France, Guatemala, Hong Kong, India, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Morocco, Netherlands, Portugal, Russian Federation, Taiwan, Thailand, Turkey & Vietnam.
Product codes and lots: Lot numbers: AGT03640 thru AGT06049

Product code CBK

K032451Class IIBird Tbird Vela VentilatorBird Products Corp. / cleared 2004-03-17

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)