Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Black...
FDA Device Recall #Z-2763-2016 — Class II — August 10, 2016
Recall Summary
| Recall Number | Z-2763-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 10, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Blackrock Microsystems, LLC |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | 81 total amplifiers |
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)
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.
Distribution Pattern
Worldwide Distribution - US Nationwide and Canada,
Lot / 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
Other Recalls from Blackrock Microsystems, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2764-2016 | Class II | Patient Cable. Part Numbers: 4460, 6735. Steril... | Aug 10, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.