Devices

Device Recall NicoletOne monitoring system version 5.20 software

Model / Serial
NicoletOne Version 5.20 software released and installed after August 07, 2006.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide, including USA, Belgium, Chile, Denmark, Italy, Japan, Poland, and Spain.
Product Description
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.
Manufacturer
Nicolet Biomedical Div of Viasys Healthcare
1 Event
- Recall of Device Recall NicoletOne monitoring system version 5.20 software

Manufacturer

Nicolet Biomedical Div of Viasys Healthcare

Manufacturer Address
Nicolet Biomedical Div of Viasys Healthcare, 5225 Verona Rd, Madison WI 53711-4497
Source
USFDA

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