Terminated

Viasys V.I.P. Bird Gold pediatric ventilator, Catalog Number 15653

FDA Recall Z-0480-2007 · Posted 2007-01-11

Recalling FirmViasys Respiratory Care, Inc.

Recall StatusTerminated

Product CodeCBK

Date Initiated2006-10-20

Date Terminated2008-09-03

Product Quantity1478

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.

K993449BIRD V.I.P. GOLD/STERLINGBird Products Corp. · 1999-12-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.