RecallWatchUSA

Home / Recalls / Medical Devices

SEER MEDICAL PTY LTD recalls Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video

Recalled September 25, 2024 · FDA recall Z-3143-2024 · SEER MEDICAL PTY

Hazard
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 Class II
Units
3,948 units
Sold at
Worldwide - US Nationwide distribution in the states of MN, NY, PA and the countries of Australia.

Description

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

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).
Manufacturer(s)
SEER MEDICAL PTY LTD
Made in
Australia

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

SEER MEDICAL PTY LTD recalls Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video | RecallWatchUSA