BEUDAMED
    FDA Recall Terminated

    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)

    Recall: Z-2764-2016 · Initiated August 10, 2016

    Recall

    Recall Number
    Z-2764-2016
    Event Number
    74893
    Firm
    Blackrock Microsystems, LLC
    FEI Number
    3007323246
    Product Code
    GWL
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    August 10, 2016
    Posted
    September 8, 2016
    Terminated
    August 21, 2017
    Address
    630 S Komas Dr, Ste 200, Salt Lake City, UT, 84108-1247

    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

    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.

    Action

    Blackrock Microsystems sent an Urgent Medical Device letter dated August 12, 2016 via email. The letter identified the affected product, problem and actions to be taken. Customers were instructed not use the amplifier in application requiring a type CF applied part; perform a physical count of the inventory of amplifiers and patient cables with the part numbers listed. For questions regarding this Correction call 801-582- 5533, ext. 240.

    Distribution

    Worldwide Distribution - US Nationwide and Canada,

    Quantity

    120 total cables