Recall Z-2763-2016— Blackrock Microsystems, LLC

Name: FDA recall Z-2763-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-10

Class II · Terminated

Class II FDA medical device recall by Blackrock Microsystems, LLC, initiated 2016-08-10, terminated 2017-08-21. It names one FDA 510(k) clearance: K090957. Product: 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: 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..

Recalling firm: Blackrock Microsystems, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-08-10
Terminated: 2017-08-21
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K090957 — BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEMI2s Micro Implantable Systems, LLC·cleared 2009-05-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.