Z-3143-2024 Class II Ongoing

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).

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

1. Product Number: SM-03-8001-INT; UDI-DI: 09355751001037; Serial Numbers: 000089, 000090, 000091, 000092, 000095, 000182, 000201, 000207, 000208, 000211, 000225, 000245, 000258, 000259, 000285, 000286, 000289, 000290, 000291, 000292, 000296, 000297, 000298, 000299, 000301, 000305, 000307, 000308, 000309, 000310, 000312, 000313, 000316, 000321, 000322, 000323, 000094, 000183, 00028, 000302, 000303, 000306, 000311. 2. Product Number: SM-01-8001; UDI-DI: 09355751001020; Serial Numbers: 000074, 000084, 000113, 000118, 000119, 000187, 000188, 000191, 000223, 000224, 000225, 000226, 000228, 000229, 000230, 000232, 000239, 000241, 000242, 000243, 000244, 000245, 000247, 000250, 000251, 000259, 000262, 000263, 000277, 000279, 000280, 000282, 000283, 000286, 000287, 000288, 000289, 000290, 000291, 000292, 000294, 000297, 000299, 000300, 000301, 000302, 000303, 000304, 000305, 000306, 000307, 000308, 000309, 000310, 000312, 000313, 000315, 000317, 000318, 000319, 000320, 000321, 000322, 000323, 000324, 000327, 000328, 000329, 000333, 000335, 000336, 000337, 000339, 000340, 000341. 3. Product Number: Monitoring Portal; UDI-DI: 09355751001136; Serial Numbers: DMPD80RCMDFX, DMPFRRE7Q1GJ, DMPFT3PDQ1KQ, DMPFT43HQ1GG, DMPFT46JQ1KQ, DMPFT4CYQ1KQ, DMPFT4X1Q1KQ, DMPFV0HGQ1KQ, DMPFV178Q1KQ, DMPFV19SQ1KQ, DMPFV1AFQ1KQ, DMPFV1AXQ1KQ, DMPFV1DBQ1KQ, DMPFV1KQQ1KQ, DMPFV1L2Q1KQ, DMPFV1LNQ1KQ, DMPFV1PRQ1KQ, DMPFV1Q8Q1KQ, DMPFV1R2Q1KQ, DMPFV1R9Q1KQ, DMPFV1SRQ1KQ, DMPFV1TEQ1KQ, DMPFV1WYQ1KQ, DMPFV1YGQ1KQ, DMPFV1ZBQ1KQ, DMPFV1ZMQ1KQ, DMPFV20DQ1KQ, DMPFV20PQ1KQ, DMPFV219Q1KQ, DMPFV21GQ1KQ, F9FF60LYQ1KQ, F9FF70Z5Q1KQ, F9FF71PAQ1KQ, F9FFQ413Q1GJ, F9FFQC4WQ1GG, F9FFQF9VQ1GG. 4. Product Number: SM-01-9005; UDI-DI: 09355751001112; Serial Number: 006240129. 5. Product Number: SM-07-8001; UDI-DI: 09355751001129; Serial Numbers: 007230809, 007230810, 007230823, 007230825, SM-07-9001_230829, 007231004, 007231005, 007231012, 007231023, 007231025, 007231102, 007231108, 007231109, 007231115, 007231120, 007231124, 00720240129, 00720240205, 00720240207, 00720240314, 007240318, 007240319, 007240327, 007240325, 007240326, 007240402, 007240403, 007240507, 007240515, 007240516, 007240522, 007240527, 007240531, 007240612, 007240613, 007240624, 007240626, 007240627, 007240628, 007240702, 007240703. 6. Product Number: SM-01-9003-US; UDI-DI: 09355751001099; Serial Numbers: 230525, 004230609, 004230913, 004231121, 004240306, 004240403, 004240424, 004240502, 004240509, 004240531, 004240603, 004240626, 004240705. 7. Product Number: SM-01-9008; UDI-DI: 09355751001105; Serial Numbers: 00223058, 00223059, 00223066, 00224008, 00224011, 00224013, 00224017, 00224018, 00224021.