Events

Recall of Blackrock NeuroPort Biopotential Signal Processing System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Blackrock Microsystems, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74893
  • Event Risk Class
    Class 2
  • Event Number
    Z-2763-2016
  • Event Initiated Date
    2016-08-10
  • Event Date Posted
    2016-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148705
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Amplifier, physiological signal - Product Code GWL
  • 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.

Device

Blackrock NeuroPort Biopotential Signal Processing System
  • Model / Serial
    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
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and Canada,
  • 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)
  • Manufacturer
    Blackrock Microsystems, LLC

Manufacturer

Blackrock Microsystems, LLC
  • Manufacturer Address
    Blackrock Microsystems, LLC, 630 S Komas Dr, Ste 200, Salt Lake City UT 84108-1247
  • Manufacturer Parent Company (2017)
    Blackrock Microsystems Llc
  • Source
    USFDA