| Class 3 Device Recall NicoletOne | |
Date Initiated by Firm | September 11, 2007 |
Date Posted | January 03, 2008 |
Recall Status1 |
Terminated 3 on December 10, 2011 |
Recall Number | Z-0126-2008 |
Recall Event ID |
45328 |
510(K)Number | K021185 |
Product Classification |
Electroencephalograph - Product Code GWQ
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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 WI 53711-4497
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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 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = GWQ
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