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)
Enforcement
- Recall Number
- Z-2764-2016
- Event ID
- 74893
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Blackrock Microsystems, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- September 14, 2016
- Initiation Date
- August 10, 2016
- Classification Date
- September 8, 2016
- Termination Date
- August 21, 2017
- Address
- 630 S Komas Dr, Ste 200, Salt Lake City, UT, 84108-1247, United States
Description
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)
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.
Part Number 4460: All Serial Numbers Part Number 6735: All Serial Numbers
Worldwide Distribution - US Nationwide and Canada,
120 total cables