GE Healthcare Finland Oy recalls TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia dete

Recalled July 12, 2023 · FDA recall Z-2032-2023 · GE Healthcare Finland Oy

Hazard

There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. · FDA Class I

Units

2707 units

Sold at

Worldwide

Description

There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

Product

TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)

Manufacturer(s)

GE Healthcare Finland Oy

Made in

Finland

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →