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U.S. Department of Health and Human Services

Class 3 Device Recall NicoletOne

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 Class 3 Recall
NicoletOne
see related information
Date Posted January 03, 2008
Recall Status1 Open
Recall Number Z-0126-2008
Recall Event ID 45328
Premarket Notification
510(K) Number
K021185 
Product Classification Full-Montage Standard Electroencephalograph - Product Code GWQ
Product Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC computer system), released and installed between December 2004 and March 2007 (Axiomtek Panel PC Model Number: 2147-671) VIASYS NeuroCare Part Numbers: 842-673800, 842-673900, 982A0421 and 982A0422. Manufactured, designed, developed and marketed by VIASYS NeuroCare Inc., Madison, WI 53711
Code Information ON040060, ON050120, ON050130, ON050168, ON050186, ON050197, ON050199, ON050203, ON050206, ON050212, ON050220, ON050231, ON060232, ON060243, ON060254, ON060256, ON060257, ON060269, ON060270, ON060272, ON060275, ON060276, ON060277, ON060278, ON060279, ON060280, ON060288, ON060290, ON060291, ON060292, ON060299, ON070301, ON070308.
Recalling Firm/
Manufacturer
Nicolet Biomedical Div of Viasys Healthcare
5225 Verona Rd
Madison, Wisconsin 53711-4497
For Additional Information Contact Technical Support
800-356-0007
Manufacturer Reason
for Recall
Display lock-up: VIASYS Healthcare NicoletOne ICU Monitor freezes up during operation when using the digital video option.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action Certified direct mail delivery of URGENT MEDICAL DEVICE FIELD CORRECTION (RECALL) were made to consignees on 9/11/07 by Nicolet Biomedical Div of Viasys Healthcare. The letter describes the product and problem. VIASYS requests that customers cease use of the video option of the device until the monitor can be replaced by VIASYS authorized personnel. Letter also requests consignees to fax or mail back the response form.
Quantity in Commerce 33
Distribution Worldwide Dsitribution - USA, Germany, Netherlands, Kuwait, Japan, Ireland, and China.
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 = TAUGAGREINING HF
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