Viasys V.I.P. Bird Sterling pediatric ventilator, Catalog Number 15654
FDA device recall Z-0481-2007 · posted 2007-01-11 · Terminated
Recall details
- Recalling firm
- Viasys Respiratory Care, Inc.
- Reason for recall
- The reason for this correction is due to the potential of a repeat ''failure to cycle'' event.
- Action taken
- 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
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 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,
- Date initiated
- 2006-10-20
- Date posted
- 2007-01-11
- Date terminated
- 2008-09-03
- Location
- Palm Springs, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIRD V.I.P. GOLD/STERLING (K993449) | Bird Products Corp. | 1999-12-20 |