FDA-Device2023-07-12Class I

TruSignal Sensitive Skin Sensor, REF TS-SE-3; 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
2097 units
Manufactured in
Kuortaneenkatu 2, N/A, Helsinki, N/A, Finland
Products
TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2028-2023

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