Home / Recalls / Blackrock Microsystems, LLC / Z-2764-2016

Z-2764-2016 Class II Terminated

Recalled by Blackrock Microsystems, LLC — Salt Lake City, UT

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: 120 total cables

Product 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)

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 4460: All Serial Numbers Part Number 6735: All Serial Numbers