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
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