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U.S. Department of Health and Human Services

Class 2 Device Recall Blackrock NeuroPort Biopotential Signal Processing System

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  Class 2 Device Recall Blackrock NeuroPort Biopotential Signal Processing System see related information
Date Initiated by Firm August 10, 2016
Date Posted September 08, 2016
Recall Status1 Terminated 3 on August 21, 2017
Recall Number Z-2763-2016
Recall Event ID 74893
510(K)Number K090957  
Product Classification Amplifier, physiological signal - Product Code GWL
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)
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
Recalling Firm/
Manufacturer		 Blackrock Microsystems, LLC
630 S Komas Dr
Ste 200
Salt Lake City UT 84108-1247
For Additional Information Contact Robert Franklin
801-582-5533
Manufacturer 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.
FDA Determined
Cause 2		 Labeling False and Misleading
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.
Quantity in Commerce 81 total amplifiers
Distribution Worldwide Distribution - US Nationwide and Canada,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GWL and Original Applicant = I2S MICRO IMPLANTABLE SYSTEMS, LLC
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