Blackrock NeuroPort Patient Cables Recalled for Incorrect Labeling
Blackrock Microsystems is voluntarily recalling 120 Patient Cables because they 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 without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Blackrock Microsystems, LLC is conducting a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System. The recall involves 120 Patient Cables, specifically Part Numbers 4460 and 6735, which are sterile within chipboard boxes inside corrugated cartons. These cables are used to record, process, and display biopotential signals such as EEG, ECoG, and ECG.
The reason for the recall is that the Neural Signal Amplifier and the Patient Cables are incorrectly labeled as Type CF Applied Parts. This labeling error affects the safety classification of the device components.
The affected products were distributed worldwide, including the United States and Canada. Users of the Blackrock NeuroPort Biopotential Signal Processing System should check their equipment for the affected part numbers and contact Blackrock Microsystems for further instructions.
The recalled product
- Product
- Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes.…
- Manufacturer
- Blackrock Microsystems, LLC
- Hazard
- Affected units
- 120
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part Number 4460: All Serial Numbers Part Number 6735: All Serial Numbers
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 Biopotential Signal Processing System Recall for Labeling Error
FDA (Devices) · 2016-09-14
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