Index-Generating Electroencephalograph Software
FDA adverse event reports and recall history for index-generating electroencephalograph software (product code OLW), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 313
- Deaths
- 1
- Injuries
- 12
- Malfunctions
- 300
Reports per year
Source: FDA adverse event reports by year received, 2017–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- Open, ClassifiedDevice Design
Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319
Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems
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