Z-2763-2016 Class II Terminated
FDA device recall Z-2763-2016 was initiated by Blackrock Microsystems, LLC on August 10, 2016 and is designated Class II. Reason for recall: 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 incorrect… The recall status is terminated (terminated August 21, 2017). Affected quantity: 81 total amplifiers.
Recall Details
- Product Type
- Devices
- Report Date
- September 14, 2016
- Initiation Date
- August 10, 2016
- Termination Date
- August 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81 total amplifiers
Product Description
Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. 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)
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US Nationwide and Canada,
Code Information
Part Number 4208: Serial Numbers 0014 and 0016 Only Part Number 5703: All Serial Numbers Part Number 5748: All Serial Numbers Part Number 5747: All Serial Numbers