NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne LTM, Sleep, nE
FDA device recall Z-0380-2007 · posted 2007-02-15 · Terminated
Recall details
- Recalling firm
- Nicolet Biomedical Div of Viasys Healthcare
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GWQ
- Quantity affected
- 75
- Distribution
- Worldwide, including USA, Belgium, Chile, Denmark, Italy, Japan, Poland, and Spain.
- Date initiated
- 2006-08-25
- Date posted
- 2007-02-15
- Date terminated
- 2011-12-10
- Location
- Madison, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRAVO MULTI-MODALITY SYSTEM (K991054) | Nicolet Biomedical, Inc. | 1999-11-03 |