Blackrock NeuroPort Biopotential Signal Processing System Recall for Labeling Error
Blackrock Microsystems is recalling 81 Neural Signal Amplifiers because the device and patient cable are incorrectly labeled as Type CF Applied Parts.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding the device's applied part classification, which fits the rubric for moderate severity involving minor labeling errors or voluntary precautionary actions.
Plain-English summary
Blackrock Microsystems, LLC is conducting a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System. The recall involves 81 Neural Signal Amplifiers with part numbers 4208, 5703, 5749, 5748, and 5747. The specific units affected include Part Number 4208 with serial numbers 0014 and 0016, and all serial numbers for part numbers 5703, 5748, and 5747.
The reason for the recall is that the Neural Signal Amplifier and the Patient Cable are incorrectly labeled as Type CF Applied Parts. The system is used to record, process, and display biopotential signals from user-supplied electrodes, including electrocorticography, electroencephalography, electromyography, electrocardiography, electrooculography, and evoked potential signals.
The affected units were distributed worldwide, including the United States and Canada. Users should contact Blackrock Microsystems for further instructions regarding this labeling correction.
The recalled product
- 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…
- Manufacturer
- Blackrock Microsystems, LLC
- Hazard
- Affected units
- 81
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Blackrock Microsystems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Blackrock Microsystems, LLC
See all →- ModerateBlackrock NeuroPort Patient Cables Recalled for Incorrect Labeling
FDA (Devices) · 2016-09-14
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