SEER MEDICAL PTY LTD: Seer Home EEG Systems Recalled for EMI Compliance and Labeling Issues

What You Should Do

1. Locate your Seer Home System components, which include the Sight Monitoring Hub, the Sense wearable, and the Monitoring Portal, to check for affected serial numbers.
2. For Product Number SM-03-8001-INT, check for these 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.
3. For Product Number SM-01-8001, check for these 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.
4. Check additional product numbers SM-01-9005 (SN 006240129), SM-01-9003-US (SNs 230525 through 004240705), and SM-01-9008 (SNs 00223058 through 00224021) against the full list provided in the recall notice.
5. Contact your healthcare provider or Seer Medical at 1-888-463-6332 for guidance on whether to continue your EEG recording or if a replacement system is necessary.
6. Contact the FDA for additional information or to report any adverse events at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products