Z-0380-2007

NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne...

Name: Z-0380-2007 NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne...
Creator: Nicolet Biomedical Div of Viasys Healthcare
Published: 2006-08-25
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2006-08-25 / Terminated / root cause: software

FDA source

Nicolet Biomedical Div of Viasys Healthcare began a recall of NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne LTM, Sleep, nEEG, vEEG and ICU monitoring Systems on 2006-08-25. The reason FDA records is "A software anomaly exists in the 5.20.1038 NicoletOne LTM, Sleep, nEEG, vEEG and ICU Monitor systems using the M, and/or C series amplifiers. If this anomaly occurs, the system will display the data for channel one in...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0380-2007
Status: Terminated
Initiated: 2006-08-25
Posted: 2007-02-15
Terminated: 2011-12-10
Recalling firm: Medtronic, Inc.
Product: NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne LTM, Sleep, nEEG, vEEG and ICU monitoring Systems.
Product code: GWQ Full-Montage Standard Electroencephalograph
Reason for recall: A software anomaly exists in the 5.20.1038 NicoletOne LTM, Sleep, nEEG, vEEG and ICU Monitor systems using the M, and/or C series amplifiers. If this anomaly occurs, the system will display the data for channel one in all channels on NicoletOne LTM, Sleep, nEEG, vEEG or ICU Monitor systems.
Root cause tag: software
FDA root cause: Other
Action: An Advisory Notice, dated August 25, 2006, was sent to all affected customers. The notice described the issues, states to discontinue use of 5.20.1038 software until updated 5.21.1039c software is installed.
Quantity in commerce: 75
Distribution: Worldwide, including USA, Belgium, Chile, Denmark, Italy, Japan, Poland, and Spain.
Product codes and lots: NicoletOne Version 5.20 software released and installed after August 07, 2006.

Product code GWQ

K991054Class IIBravo Multi-Modality SystemNicolet Biomedical, Inc. / cleared 1999-11-03

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)