Seer Home System is an ambulatory electroencephalograph — Class II medical device recall Z-3143-2024
Ongoing recall by SEER MEDICAL PTY LTD, reported 2024-09-25, distributed nationwide. During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnet
| Recall number | Z-3143-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SEER MEDICAL PTY LTD, Melbourne, Australia |
| Recall initiated | 2024-08-12 |
| Classified | 2024-09-13 |
| Reported by FDA | 2024-09-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 3,948 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 09355751001020, 09355751001037, 09355751001099, 09355751001105, 09355751001112, 09355751001129, 09355751001136 |
| Serial numbers | 000074, 000084, 000089, 000090, 000091, 000092, 000094, 000095, 000113, 000118, 000119, 000182, 000183, 000187, 000188, 000191, 000201, 000207, 000208, 000211, 000223, 000224, 000225, 000226, 000228 and 168 more |
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).
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3143-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.