Recall Z-3143-2024 ยท GWQ Full-Montage Standard Electroencephalograph
SEER MEDICAL PTY LTD
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).
| Date | Sep 13, 2024 (initiated Aug 12, 2024) |
| Status | Open, Classified |
| Reason | 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 |
| Root 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 inter |
| Quantity | 3,948 units |
| Distribution | Worldwide - US Nationwide distribution in the states of MN, NY, PA and the countries of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212788 | Seer Home Seer Medical Pty, Ltd., Jun 16, 2022 |