Blackrock Microsystems, LLC: Medical Device Recall in 2016 - (Recall #: Z-2763-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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)

Product Classification:

Class II

Date Initiated: August 10, 2016

Date Posted: September 14, 2016

Recall Number: Z-2763-2016

Event ID: 74893

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.

Status: Terminated

Product Quantity: 81 total amplifiers

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

Distribution Pattern:

Worldwide Distribution - US Nationwide and Canada,

Voluntary or Mandated:

Voluntary: Firm initiated