Reported Sep 14, 2016 · Terminated
Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Blackrock NeuroPort…
Blackrock Microsystems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Blackrock Microsystems, LLC · 630 S Komas Dr · Salt Lake City, UT · 84108-1247
Is this the product you have?
- Neural Signal Amplifier
- Part Numbers
42085703574957485747
- Product UsageThe Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes
- Biopotential signals includeElectrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP)
- Lot codes and dates
- Part Number 4208Serial Numbers 0014
- and 0016 Only Part Number 5703All
- Serial Numbers Part Number 5748All
- Serial Numbers Part Number 5747All Serial Numbers
- Amount recalled
- 81 total amplifiers
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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