FDA-Device2023-07-12Class I
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter
GE Healthcare Finland Oy
Hazard
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Sold states
Worldwide
Affected count
708 devices
Manufactured in
Kuortaneenkatu 2, N/A, Helsinki, N/A, Finland
Products
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2033-2023Don't want to check this manually?
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