Viasys V.I.P. Bird Sterling pediatric ventilator, Catalog Number 15654
FDA Recall Z-0481-2007 · Posted 2007-01-11
Recalling FirmViasys Respiratory Care, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2006-10-20
Date Terminated2008-09-03
Product Quantity539
Reason for Recall
The reason for this correction is due to the potential of a repeat ''failure to cycle'' event.
Firm 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.
Root Cause
Other
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.