The TruSignal sensors were recalled because of their potential to decrease the energy delivered to the heart during defibrillation without notifying the care provider, which presents a risk of preventing lifesaving therapy delivery in critical situations
FDA labels GE HealthCare's recall of TruSignal SpO2 sensors as Class I. (Credit: The U.S. Food and Drug Administration/Wikimedia Commons)
GE HealthCare’s recall of TruSignal SpO2 sensors has been classified by the US Food and Drug Administration (FDA) as Class I, which indicates the most severe type of recall.
According to the FDA, Class I recall means that the use of the recalled malfunctioning devices could lead to serious injuries or death.
The TruSignal sensors were recalled due to their potential to decrease the energy delivered to the heart during defibrillation without notifying the care provider. This poses a risk of preventing lifesaving therapy delivery in critical situations.
Hospitalised patients requiring defibrillation for cardiac arrest are particularly at risk from this issue, said the FDA.
As per the regulator, the affected sensors may also inadvertently expose patients to electrical currents from other sources or provide inaccurate SpO2 measurements, potentially influencing treatment decisions.
GE HealthCare is yet to get any reports of injuries or death for the issue.
The company initiated the recall on 19 May 2023. A total of 7,559 are being recalled in the US, which were distributed between 1 January 2021 and 4 May 2023.
According to the FDA, the problem could impact both adults and children whose SpO2 and pulse rates are continuously monitored using TruSignal SpO2 sensors. Additionally, healthcare providers relying on TruSignal SpO2 sensors to monitor adult and pediatric patients are also affected by this issue.
The recalled products are TruSignal Adult Pediatric Sensor, TruSignal AllFit Sensor, TruSignal Sensitive Skin Sensor, TruSignal Wrap Sensor, TruSignal Ear Sensor, TruSignal Integrated Ear Sensor with GE Connector, TruSignal Integrated Ear Sensor with Datex Connector, TruSignal Integrated Ear Sensor with Datex Connector, and TruSignal Integrated Ear Sensor with Ohmeda Connector.
TruSignal sensors are designed to continuously monitor the arterial oxygen saturation (SpO2) and pulse rate by placing a sensor on the skin, ensuring sufficient oxygen levels in the blood to support proper bodily functions.
The information provided by the sensors assists care providers in making informed treatment decisions, which ensures the well-being of patients.