Seer Medical recalls specific models of home EEG systems due to electromagnetic compatibility testing failures. Affected units may not meet safety standards for RF emissions.
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
Seer Medical is recalling certain home EEG systems because they failed electromagnetic compatibility testing. This means the devices might not meet safety standards for radio frequency emissions, which could lead to interference with other electronics or potential safety risks.
The devices were not properly tested for electromagnetic compatibility (EMC) and may not meet international safety standards (IEC 60601-1-2). This could cause interference with other electronic devices or potential safety issues due to improper RF emissions.
Home users of the Seer Home System EEG devices with the listed serial numbers or product numbers are affected. People using these systems for extended EEG or video EEG recordings are most at risk.
Check the product number, serial numbers, or UDI-DI codes listed in the recall notice. Affected units include specific models with serial numbers like 000089, 000090, and others as detailed in the recall.
Review the product number, serial numbers, or UDI-DI codes to confirm if your device is affected.
The Seer Home System is an ambulatory electroencephalograph (EEG) system for at-home use to record extended EEG and video EEG (vEEG) recordings.
The devices failed electromagnetic compatibility (EMC) testing and may not meet safety standards for radio frequency emissions as per IEC 60601-1-2.
Check the product number, serial numbers, or UDI-DI codes listed in the recall notice. Affected units include specific models with serial numbers like 000089, 000090, and others as detailed in the recall.
We’ve drafted a message you can send Seer Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-3143-2024 — Seer Medical Seer Medical Hello, I own a Seer Medical that is covered by recall Z-3143-2024 from Seer Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
