Recall Z-0481-2007 ยท CBK Ventilator, Continuous, Facility Use
Viasys Respiratory Care, Inc.
Viasys V.I.P. Bird Sterling pediatric ventilator, Catalog Number 15654
| Date | Jan 11, 2007 (initiated Oct 20, 2006) |
| Status | Terminated |
| Reason | The reason for this correction is due to the potential of a repeat ''failure to cycle'' event. |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993449 | BIRD V.I.P. GOLD/STERLING Bird Products Corp., Dec 20, 1999 |