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U.S. Department of Health and Human Services

Class 3 Device Recall NicoletOne

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 Class 3 Device Recall NicoletOnesee related information
Date Initiated by FirmSeptember 11, 2007
Date PostedJanuary 03, 2008
Recall Status1 Terminated 3 on December 10, 2011
Recall NumberZ-0126-2008
Recall Event ID 45328
510(K)NumberK021185 
Product Classification Electroencephalograph - Product Code GWQ
ProductViasys 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 WI 53711-4497
For Additional Information ContactTechnical 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		Component design/selection
ActionCertified 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 Commerce33
DistributionWorldwide Dsitribution - USA, Germany, Netherlands, Kuwait, Japan, Ireland, and China.
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 = GWQ
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