Z-0126-2008

Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC...

Name: Z-0126-2008 Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC...
Creator: Nicolet Biomedical Div of Viasys Healthcare
Published: 2007-09-11
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2007-09-11 / Terminated / root cause: design

FDA source

Nicolet Biomedical Div of Viasys Healthcare began a recall of Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC computer system), released and installed between... on 2007-09-11. The reason FDA records is "Display lock-up: VIASYS Healthcare NicoletOne ICU Monitor freezes up during operation when using the digital video option". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0126-2008
Status: Terminated
Initiated: 2007-09-11
Posted: 2008-01-03
Terminated: 2011-12-10
Recalling firm: Medtronic, Inc.
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
Product code: GWQ Full-Montage Standard Electroencephalograph
Reason for recall: Display lock-up: VIASYS Healthcare NicoletOne ICU Monitor freezes up during operation when using the digital video option.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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.

Product code GWQ

K021185Class IINervus MonitorTaugagreining HF / cleared 2002-07-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)