Class 2 Device Recall Seer Home System

• Date Initiated by Firm: August 12, 2024
• Date Posted: September 13, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3143-2024
• Recall Event ID: 95138
• 510(K)Number: K212788
• Product Classification: Full-montage Standard Electroencephalograph - Product Code GWQ
• Product: 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).
• Code Information: 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.
• Recalling Firm/ Manufacturer: SEER MEDICAL PTY LTD; 278-284 Queensberry St; Melbourne Australia
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Under Investigation by firm
• Action: Seer Medical notified consignees on 08/12/2024, via email. Consignees were instructed that no new new Seer Home studies can be scheduled or ordered. Any systems in the possession of patients who are not currently in a vEEG study using the Seer Home System will be returned to Seer Medical. Currently ongoing studies with patients that have implanted or wearable medical devices that may be susceptible to electrical interference should be halted immediately. Currently ongoing studies with patients who do not have implantable or wearable medical devices that may be susceptible to electrical interference may complete their study. Seer Home will be unavailable for an indefinite period of time, therefore any future scheduled studies must be moved to other technologies or canceled. Customers were also instructed to identify and quarantine all Seer Medical equipment and consumables that are not in use, coordinate with Seer to return the equipment, and complete and return the acknowledgement form. Seer Medical sent an updated letter to consignees via email on 08/13/2024. The letter provided updated information on the reason for recall to include how they were not compliant with Electromagnetic Compatibility (EMC) testing. Additionally, it was emphasized to customers to immediately halt any ongoing studies as patients with neurostimulators, pacemakers, cardiac defibrillators, and continuous glucose monitors are the population at greatest risk and the benefit of continuing these studies does not outweigh the risk.
• Quantity in Commerce: 3,948 units
• Distribution: Worldwide - US Nationwide distribution in the states of MN, NY, PA and the countries of Australia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GWQ