Sam Brusco, Associate Editor07.31.23
The U.S. Food and Drug Administration (FDA) has identified GE HealthCare’s May 19 recall of its TruSignal SpO2 sensors as Class I.
The sensors continuously monitor the amount of oxygen in the blood flowing through the arteries and pulse rate through a sensor on the skin. The sensors help ensure patients have enough oxygen in their blood to keep their bodies functioning and give care providers info to make decisions about treatment.
GE HealthCare recalled malfunctioning TruSignal sensors that may reduce the amount of energy sent to the heart during defibrillation without transmitting an alert to the care provider. This can prevent life-saving therapy in a critical situation.
The issue is most dangerous for hospitalized patients why might need defibrillation for cardiac arrest. The affected sensors can also unintentionally expose patients to electrical currents from other sources or offer inaccurate SpO2 measurements, which can affect treatment decisions.
FDA said GE HealthCare hasn’t yet received reports of injuries or death related to this issue.
GE advised customers to use an alternate method for SpO2 monitoring, which can include TruSignal sensors not impacted or another SpO2 device. If alternate methods aren’t available, the company recommended using affected sensors, provided they haven’t been saturated with fluids.
The sensors continuously monitor the amount of oxygen in the blood flowing through the arteries and pulse rate through a sensor on the skin. The sensors help ensure patients have enough oxygen in their blood to keep their bodies functioning and give care providers info to make decisions about treatment.
GE HealthCare recalled malfunctioning TruSignal sensors that may reduce the amount of energy sent to the heart during defibrillation without transmitting an alert to the care provider. This can prevent life-saving therapy in a critical situation.
The issue is most dangerous for hospitalized patients why might need defibrillation for cardiac arrest. The affected sensors can also unintentionally expose patients to electrical currents from other sources or offer inaccurate SpO2 measurements, which can affect treatment decisions.
FDA said GE HealthCare hasn’t yet received reports of injuries or death related to this issue.
GE advised customers to use an alternate method for SpO2 monitoring, which can include TruSignal sensors not impacted or another SpO2 device. If alternate methods aren’t available, the company recommended using affected sensors, provided they haven’t been saturated with fluids.