Seer Home System is an ambulatory electroencephalograph recall: Labeling Error
Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and…
Why was Seer Home System is an ambulatory electroencephalograph 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and…
- Recalling firm
- SEER MEDICAL PTY LTD
- Quantity
- 3,948 units
- Distribution
- Worldwide - US Nationwide distribution in the states of MN, NY, PA and the countries of Australia.
- Recall date
- September 25, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)