Company:Viasys Healthcare .
Date of Enforcement Report 4/15/2009
Class:ll
PRODUCT
a) Viasys Healthcare , Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0469 Sonara Unilateral. The Sonara Transcranial Doppler system is a medical ultrasound device for noninvasively measuring the blood flow velocities in arteries and veins, Recall # Z-0998-2009;
b) Viasys Healthcare , Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0470 Sonara Bilateral. The Sonara Transcranial Doppler system is a medical ultrasound device for noninvasively measuring the blood flow velocities in arteries and veins, Recall # Z-0999-2009
REASON
Internal testing has identified several scenarios where unexpected System lockups, shutdowns or system errors would render the Sonara unavailable for use until the Sonara can be restarted. These issues can be corrected by installing the Version 6.0 b045 software updating the Audio Driver and updating to XP Service Pack 3. Additionally, improper wiring could cause the cooling fan to not operate properly. This could present itself as a lockup within approximately 20 minute of initial operation. Installation of the items will help prevent the occurrence of unexpected lockups which could result in the loss of the display information during monitoring and could lead to serious consequences during surgical monitoring.
RECALLING FIRM/MANUFACTURER
Cardinal Health, Inc., Madison , WI , by letter dated January 12, 2009 beginning the week of February 2, 2009 and continuing into week of February 9, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
100 systems
DISTRIBUTION
Nationwide and Internationally
