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Seer Home System is an ambulatory electroencephalograph… recallZ-3143-2024 · Seer Medical Pty Ltd · initiated Aug 12, 2024

Class II Open, Classified All recalls posted in September 2024

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Seer Medical Pty Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-3143-2024
Recall class
Class II
Status
Open, Classified
Initiated by the company
Aug 12, 2024
Posted by the FDA
Sep 13, 2024
Recalling firm
Seer Medical Pty Ltd
Quantity
3,948 units
Product code
GWQ
FDA submissions
K212788
Distribution
Worldwide - US Nationwide distribution in the states of MN, NY, PA and the countries of Australia.

Product description

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 (models, lots, serial numbers)

Show the full code information (3k characters)

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.

Devices named in this recall

7 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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