VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.
FDA device recall Z-0638-2007 · posted 2007-03-20 · Terminated
Recall details
- Recalling firm
- Viasys Respiratory Care, Inc.dba Bird Products
- Reason for recall
- The graphical user interface may become slow in its response and in some cases non-responsive. Under some circumstances this situation may cause the ventilator to delay the annunciation of alarms.
- Action taken
- On January 31, 2007, 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 January 31, 2007, a product notification kit (including a product notification letter, download software, download instruction sheets and installation verification fax-back sheets) were mailed to all international customers via register mail. Consignees are informed in the notification letter that replacement software, replacement instructions, and installation verification forms are included in their recall package. Domestic Consignees will have product corrected by VIASYS service personnel. Self address postage paid envelopes will be provided with notifications to aid in effectiveness checks
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 878
- Distribution
- Worldwide Distribution ---USA and countries of Bangladesh, Bosnia, Brazil, China, Czech Republic, Ecuador, Estonia, Finland, France, Guatemala, Hong Kong, India, Israel, Italy, Japan, Latvia, Lithuani
- Date initiated
- 2007-01-31
- Date posted
- 2007-03-20
- Date terminated
- 2008-09-18
- 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 TBIRD VELA VENTILATOR (K032451) | Bird Products Corp. | 2004-03-17 |