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U.S. Department of Health and Human Services

Class 3 Device Recall VIASYS Healthcare Disposable Surface Electrodes

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 Class 3 Device Recall VIASYS Healthcare Disposable Surface Electrodessee related information
Date Initiated by FirmApril 28, 2006
Date PostedJuly 25, 2006
Recall Status1 Terminated 3 on December 27, 2006
Recall NumberZ-1254-06
Recall Event ID 35416
510(K)NumberK010019 
Product Classification Disposable Surface Electrodes - Product Code GXZ
ProductVIASYS Healthcare Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only. Manufactured in the U.S.A. for VIASYS Healthcare, 5225 Verona Road, Bldg 2, Madison, WI USA 53711-4495..Each box contains 10 pouches of Bar Electrodes and each pouch contains 10 electrodes
Code Information Lot 604664
Recalling Firm/
Manufacturer		 Nicolet Biomedical Div of Viasys Healthcare
5225 Verona Rd
Madison WI 53711-4497
Manufacturer Reason
for Recall		The Bar Electrodes do not meet performance specification for electrode impedance. A manufacturing defect was discovered in disposable bar electrodes, part number 019-435600, lot 604664, that has the potential to reduce the amplitude of a motor or sensory nerve action potential. These possible lower amplitudes will be measured only if the bar electrode is used as a bar.
FDA Determined
Cause 2		Other
ActionCommunication on April 28, 2006 by phone, followed by Certified Mail, with return receipt to confirm receipt of information . The letter describes the issue and asks that affected product be returned. The customer notification allows the user the option of using the Bar Electrode as 2 separate electrodes, as described in the Instructions for Use.
Quantity in Commerce53 boxes, 10 electrodes per pouch, 10 pouches per box
DistributionWorld wide including the states of AL, CA, CT, FL, IA, NH, NY, OH, TX. and countries of Canada, Japan, Poland
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GXZ
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