Seer Home EEG System Recalled for EMC Non-Compliance
Seer Home System ambulatory EEG devices were recalled due to electromagnetic compatibility non-compliance and manufacturing control deficiencies. The issue may affect signal recording reliability in home EEG monitoring.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II recall of a medical device used for critical neurological monitoring represents a risk of harm due to EMC non-compliance and manufacturing control deficiencies that may affect signal integrity. No illnesses or injuries have been reported.
Plain-English summary
The FDA is recalling the Seer Home System, an ambulatory electroencephalograph (EEG) system designed for extended EEG and video EEG monitoring at home. The system includes the Sight Monitoring Hub, Sense wearable device, and associated accessories.
The recall was initiated after investigations revealed that the systems do not comply with electromagnetic compatibility (EMC) testing standards according to IEC 60601-1-2. Design changes to the system were not assessed for equivalent EMC performance, and systems were manufactured and distributed without proper design change and manufacturing controls. Additionally, the systems were distributed with labeling deficiencies.
3,948 units were distributed worldwide, with US distribution in Minnesota, New York, and Pennsylvania, as well as in Australia.
Patients and healthcare providers using affected units should contact SEER MEDICAL PTY LTD for guidance regarding the recalled devices.
The recalled product
- 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 comp
- Manufacturer
- SEER MEDICAL PTY LTD
- Hazard
- electromagnetic-interference
- design-control-deficiency
- labeling-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1. Product Number: SM-03-8001-INT
- UDI-DI: 09355751001037
- Serial Numbers: 000089
- 000090
- 000091
- 000092
- 000095
- 000182
- 000201
- 000207
- 000208
- 000211
- 000225
- 000245
- 000258
- 000259
- 000285
- 000286
- 000289
- 000290
Distribution
Distributed nationwide across the United States.
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