Reported Sep 14, 2016 · Terminated
Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. Product Usage: The…
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?
- Patient Cable
- Part Numbers4460, 6735. Sterile within Chipboard Boxes within corrugated cartons
- 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 4460All
- Serial Numbers Part Number 6735All Serial Numbers
- Amount recalled
- 120 total cables
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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