Z-0481-2007

Viasys V.I.P. Bird Sterling pediatric ventilator, Catalog Number 15654

Name: Z-0481-2007 Viasys V.I.P. Bird Sterling pediatric ventilator, Catalog Number 15654
Creator: Viasys Respiratory Care, Inc.
Published: 2006-10-20
License: https://open.fda.gov/license/

ZOLL Palm Springs / initiated 2006-10-20 / Terminated

FDA source

Viasys Respiratory Care, Inc. began a recall of Viasys V.I.P. Bird Sterling pediatric ventilator, Catalog Number 15654 on 2006-10-20. The reason FDA records is "The reason for this correction is due to the potential of a repeat ''failure to cycle'' event". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0481-2007
Status: Terminated
Initiated: 2006-10-20
Posted: 2007-01-11
Terminated: 2008-09-03
Recalling firm: ZOLL Palm Springs
Product: Viasys V.I.P. Bird Sterling pediatric ventilator, Catalog Number 15654
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: The reason for this correction is due to the potential of a repeat ''failure to cycle'' event.
FDA root cause: Other
Action: On November 2, 2006, 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 November 4, 2006, a product notification letter was mailed to all international customers via registed mail. Consignees are informed in the notification letter that replacement software, replacement instructions, and installation verification forms are included in their recall package.
Quantity in commerce: 539
Distribution: Worldwide including USA, Canada, Estonia, Belgium, Saudi Arabia, Brazil, Thailand, United Arab Emirates, Syria, Portugal, Jordan, Italy, Latvia, Hong Kong China, Ecuador, Jamaica, Dominican Republic, New Zealand, Australia, Czech Republic, Bolivia, Austria, Greece, United Kingdom (England), Turkey, Chile, Japan, India, Mexico, Uruguay, Algeria, Vietnam, Costa Rica, Ireland, Switzerland, Bahamas, Singapore, South Africa, Philippines, Spain, France, Peru, Lebanon, Taipei, Malaysia, Netherlands, South Korea, Israel & Slovak Republic
Product codes and lots: Serial numbers: AAM01128 to ABMO1015 for Domestic Customers and AAM01119 to ACMO1142 for International Customers

Product code CBK

K993449Class IIBird V.i.p. Gold/sterlingBird Products Corp. / cleared 1999-12-20

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)