The Recall Desk

FDA (Devices) recall action 74893

Blackrock Microsystems, LLC recalled 2 products on 2016-09-14

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-09-14
Critical
0
Units
201

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2016-09-14

    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.

    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: El
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    Distribution
    0 states
  • ModerateFDA (Devices)··2016-09-14

    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.

    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. B
    Category
    Distribution
    0 states