The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Names:
- 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
- TruSignal Integrated Ear Sensor with Ohmeda Connector
- Distribution Dates: January 1, 2021 to March 4, 2023
- Devices Recalled in the U.S.: 7,559
- Date Initiated by Firm: May 19, 2023
Device Use
TruSignal sensors continuously monitor the amount of oxygen found in the blood flowing through the arteries (arterial oxygen saturation or SpO2) and pulse rate through a sensor placed on the skin. The sensors are designed and tested to help ensure patients have enough oxygen in their blood to keep their bodies functioning and to give care providers information to make treatment decisions.
Reason for Recall
GE HealthCare is recalling malfunctioning TruSignal sensors that 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. Affected sensors may also unintentionally expose patients to electrical currents from other sources or may provide inaccurate measurements of SpO2, which can impact treatment decisions.
Use of defective TruSignal SpO2 Sensors may cause serious injuries or death.
GE HealthCare has received four reported injuries and no reported deaths for this issue.
Who May be Affected
- Adults and children whose SpO2 and pulse rate are continuously monitored using TruSignal SpO2 sensors.
- Healthcare providers who use TruSignal SpO2 sensors to monitor adult and pediatric patients.
