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U.S. Department of Health and Human Services

Class 2 Device Recall Viasys Healthcare, Sonora Transcranial Doppler (TCD) System

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 Class 2 Recall
Viasys Healthcare, Sonora Transcranial Doppler (TCD) System
see related information
Date Posted April 07, 2009
Recall Status1 Open
Recall Number Z-0998-2009
Recall Event ID 50875
Premarket Notification
510(K) Number
K060421 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product 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.
Code Information Serial Numbers: PWH0297 PWH0212 PWH0221 PWH0309 PWH0246 PWH0250 PWH0223 PWH0429 PWH0245 PWH0292 PWH0298 PWH0214 PWH0211 PWH0210 PWH0219 PWH0216 PWH0224 PWH0215 PWH0213 PWH0220 PWH0253 PWH0252 PWH0254 PWH0221 PWH0218 PWH0217 06-2506 06-2504 05-2506 PWH0251 06-2501 06-2500 06-2503 06-2502 05-2502 and 05-2500.
Recalling Firm/
Manufacturer
Cardinal Health, Inc
5225 Verona Rd
Madison, Wisconsin 53711-4497
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
DESIGN: Device Design
Action 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 36 systems
Distribution 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) Database 510(K)s with Product Code = IYN and Original Applicant = VIASYS HEALTHCARE, INC.
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