medical Class I Updated 2023-07-12

GE Healthcare Finland Oy recalls TruSignal Integrated Ear Sensor with Datex Connector, REF TS

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Worldwide
Lot/Code Info: GTIN 00840682103428
View official government recall

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