Device product
Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP)
Z-2764-2016
Product summary
- Event
- Event 74893
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 total cables
- Official record key
device-enforcement:Z-2764-2016
Official wording
Reason: Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient Cable are incorrectly labeled as Type CF Applied Parts.
Code information: Part Number 4460: All Serial Numbers Part Number 6735: All Serial Numbers
Distribution pattern: Worldwide Distribution - US Nationwide and Canada,
Derived failure modes
-
Labeling or packaging
incorrectly labeled