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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 Device Recall Viasys Healthcare, Sonora Transcranial Doppler (TCD) System see related information
Date Posted April 07, 2009
Recall Status1 Terminated on July 03, 2012
Recall Number Z-0998-2009
Recall Event ID 50875
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 WI 53711-4497
For Additional Information Contact
608-441-5000
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
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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