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U.S. Department of Health and Human Services

Class 2 Device Recall BMSI MicroJack

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 Class 2 Recall
BMSI MicroJack
see related information
Date Posted September 20, 2007
Recall Status1 Open
Recall Number Z-1225-2007
Recall Event ID 38424
Premarket Notification
510(K) Number
K891405 
Product Classification Full-Montage Standard Electroencephalograph - Product Code GWQ
Product BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during electroencephalography (EEG) /Epilepsy Monitoring evaluations with various EEG monitoring systems. The MicroJack is used with BMSI Models 2000, 3000, 4000, 5000 & 6000, and is used with the BMSI kit upgraded with NicoletOne. Nicolet Biomedical, Inc.
Code Information Models BMSI 2000, 3000, 4000, 5000 & 6000 and BMSI kit upgraded with NicoletOne.
Recalling Firm/
Manufacturer
Nicolet Biomedical Div of Viasys Healthcare
5225 Verona Rd
Madison, Wisconsin 53711-4497
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The BMSI "MicroJack" patient interface electrode connection device used with the EEG monitor systems was found to be mis-wired. A complainant alleged that during depth electrode EEG study of a patient in preparation for brain surgery there was an observation that was perceived as non-logical data output.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action VIASYS will initiate a field correction for units that have been distributed. The correction consists of testing the units and replacing those that have been found to contain the defect. Method of communication will be by certiified mail to identify consignees and receipt of the communication will be tracked. Letters "Viasys HealthCare Urgent Medical Device Field Correction (Recall)" were sent 7/17/07 to both domestic and international customers.
Quantity in Commerce 2102
Distribution Worldwide, including USA, ISRAEL, LITHUANIA, RUSSIA, FRANCE, IRELAND, UNITED KINGDOM , SPAIN, YEMEN, JAPAN, TAIWAN, KOREA, CHINA, SAUDI ARABIA, HONG KONG, INDIA, COLOMBIA, BRAZIL, GERMANY, CANADA, DENMARK, ITALY, MEXICO, and THAILAND.
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 = GWQ and Original Applicant = BUCKMAN CO., INC.
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