R-40

LIFELINES LIMITED · Model EEG Amplifier + BT Kit · UDI-DI 05060275450431

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510(k) clearances

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2016-08-10	Blackrock Microsystems, LLC	Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient
2016-08-10	Blackrock Microsystems, LLC	Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient
2013-02-27	Natus Neurology Incorporated	Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overhea
2010-03-26	I2s Micro Implantable Systems Llc	Component of cranial array may not allow sufficient tightening to maintain inserter position.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.