SEER MEDICAL PTY LTD recalls Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and vide…

Recall date

August 12, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3143-2024

FDA classification

Class II

Brand / firm

SEER MEDICAL PTY LTD

Sold / distributed

Worldwide - US Nationwide distribution in the states of MN, NY, PA and the countries of Australia.

Why it was recalled

During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF radiated emissions may not be reasonably equivalent to the current product due to design changes in the system. A new CAPA was opened to investigate the radiated emissions compliance issues. - Seer Home Systems distributed and retained in the field were not compliant with Electromagnetic Compatibility (EMC) testing according to IEC 60601-1-2 - Seer Home Systems, including accessories, were manufactured and distributed without application of proper design change and manufacturing controls - Seer Home Systems were distributed with labeling deficiencies

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable EEG Wires, WaterTabs, WaterTabs Application Kit, and Take-home Kit).