Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Seer Home System is an ambulatory electroencephalograph (EEG) system intended Recalled by SEER MEDICAL PTY LTD Due to During CAPA investigations of sight production inconsistencies, it...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SEER MEDICAL PTY LTD directly.
Affected Products
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).
Quantity: 3,948 units
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SEER MEDICAL PTY LTD
SEER MEDICAL PTY LTD has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report