FDA Medical Device Recalls (openFDA)
Nicolet Biomedical Div of Viasys Healthcare: 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.
- Recall number
- Z-0380-2007
- Recalling firm
- Nicolet Biomedical Div of Viasys Healthcare
- 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.
- Status
- Terminated
- Initiated
- 2006-08-25
- Posted
- 2007-02-15
- Terminated
- 2011-12-10
- Reason
- 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
- 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
- 75
- Distribution
- Worldwide, including USA, Belgium, Chile, Denmark, Italy, Japan, Poland, and Spain.
- Lot, serial or model codes
- NicoletOne Version 5.20 software released and installed after August 07, 2006.
- 510(k) numbers
- ["K991054"]
- PMA numbers
- not on file
- Product code
- GWQ
- Firm FEI
- 3010611950
- Firm city
- Madison
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28