Viasys Respiratory Care, Inc.dba Bird Products VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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