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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-0999-2009
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: 982A0470 Sonara Bilateral.

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:
PWH0267
PWH0316
PWH0269
PWH0284
PWH0201
PWH0269
PWH0264
PWH0259
PWH0226
PWH0280
PWH0278
PWH0277
05-2507
05-2505
05-2504
06-2512
PWH0262
PWH0209
PWH0274
PWH0263
PWH0239
PWH0203
PWH0244
PWH0341
PWH0257
PWH0240
PWH0315
PWH0225
PWH0234
PWH0340
PWH0232
PWH0205
PWH0204
PWH0282
PWH0230
PWH0208
PWH0265
PWH0265
PWH0207
PWH0200
PWH0270
PWH0202
PWH0281
PWH0279
PWH0227
PWH0255
PWH0273
PWH0206
06-2505
06-2509
05-2508
06-2508
PWH0238
PWH0237
PWH0276
PWH0229
PWH0236
PWH0228
PWH0241
06-2507
PWH0258
PWH0242
PWH0271 and
PWH0233.
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 64 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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