GE Recalls TruSignal SpO2 Sensors

GE HealthCare has recalled its TruSignal SpO2 Sensors due to malfunction issues that may reduce defibrillation energy or expose patients to unintended voltage because of inaccurate readings. The skin-placed sensors are used to continuously monitor oxygen levels in the blood flowing through the arteries (arterial oxygen saturation or SpO2) and pulse rate.

A recall notice says the “malfunctioning TruSignal sensors may reduce the amount of energy sent to the heart during defibrillation without any notification to the care provider, which could prevent delivery of lifesaving therapy in a critical situation. This issue is most hazardous to hospitalized patients who may need defibrillation for cardiac arrest.” Additionally, it says affected sensors may also unintentionally expose patients to electrical currents from other sources or may provide inaccurate measurements of SpO2, which can affect treatment decisions.

GE has reported four injuries and no deaths related to the issue.