Official recall record
Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordin
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-08-12
- Country of alert
- Australia
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 09355751001037
- Brand on record
- SEER MEDICAL PTY LTD
What the authority reported
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 to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.