GE Healthcare Finland Oy recalls TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter

Recalled July 12, 2023 · FDA recall Z-2027-2023 · 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

36337 devices

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 AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter

Manufacturer(s)

GE Healthcare Finland Oy

Made in

Finland

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