Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0480-2007

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

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

Viasys Respiratory Care, Inc. began a recall of Viasys V.I.P. Bird Gold pediatric ventilator, Catalog Number 15653 on . The reason FDA records is "The reason for this correction is due to the potential of a repeat ''failure to cycle'' event". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0480-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
ZOLL Palm Springs
Product
Viasys V.I.P. Bird Gold pediatric ventilator, Catalog Number 15653
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
1478
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: AAM01001 to AMMO1590 + KJI01178 for Domestic Customers and AAMO1648 to AEM01298 for International Customers