| ||Class 2 Recall|
Viasys Healthcare, Sonora Transcranial Doppler (TCD) System
||April 07, 2009
|Recall Event ID
System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
||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.
|Cardinal Health, Inc
5225 Verona Rd
Madison, Wisconsin 53711-4497
|Internal testing has identified several 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 op
|DESIGN: Device Design
||Consignees were sent a Cardinal Health "Urgent: Medical Device Correction" letter dated January 12, 2009 beginning the week of February 2, 2009 and continuing into week of February 9, 2009. The letter was addressed to customers describing the problems and systems affected and solutions. Cardinal Health requested customers to complete the actions listed in the letter to install the Field Correction and return the completed "Verification Form" via mail, e-mail or fax to Cardinal Health-NeuroCare. Further information can be obtained by calling 1-800-356-0007 ext 2191 or fax to 1-877-244-3805.
|Quantity in Commerce
||Worldwide Distribution -- USA including states of FL, DC, LA, NJ, NY, PA, TN, TX, WI, CA, MO, and LA and countries including THAILAND, SINGAPORE, SERBIA-MONTENEGRO, PORTUGAL, PHILIPPINES, POLAND, NORWAY, NETHERLANDS, KOREA, ITALY, ISRAEL, HUNGARY, HONG KONG, GREAT BRITAIN, SPAIN, GERMANY, CZECH REPUBLIC, SWITZERLAND, CANADA, BULGARIA, and BOSNIA-HERZEGOVINA.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = IYN and Original Applicant = VIASYS HEALTHCARE, INC.