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Terminated

VIASYS AVEA Ventilator, Catalog numbers: 17312-00 (USA Standard with Compressor Version)

FDA Recall Z-0986-2008 · Posted 2008-05-14

Recalling FirmViasys Respiratory Care, Inc.dba Bird Products
Recall StatusTerminated
Product CodeCBK
Date Initiated2007-12-17
Date Terminated2008-05-13
Product Quantity28

Reason for Recall

Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.

Firm Action

On December 18, 2007, a product notification letter was mailed to all customers in the United States via overnight carrier (registed mail) and a product notification letter was mailed to all international customers via Federal Express. The recall letter informed the customers of the problem and also inform them that a Cardinal Health (Viasys) service representative will be contacting them immediately to arrange & service their ventilator. For futher information please contack Andrea von Muller at 760-778-7323.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution --- USA including states of AL, CA, MA, NM, NV, and NY and country of Italy.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062093AVEA VENTILATORViasys Respiratory Care, Inc. · 2006-09-20K022674BIRD AVEA VENTILATORBird Products Corp. · 2002-11-06K013642AVEABird Products Corp. · 2002-05-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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