The FDA issued a notice labeling the GE HealthCare
(Nasdaq: GEHC)
SpO2 sensor recall as Class I, the most serious kind.
GE HealthCare initiated the recall of nine models of its TruSignal SpO2 sensor on May 19, 2023. The recall includes 7,559 devices distributed between Jan. 1, 2021, and March 4, 2023.
A GE HealthCare spokesperson shared the following statement with MassDevice:
“Patient safety is our top priority. We are informing customers of the potential issue and providing them with interim instructions until the affected products are replaced. There are no reports of patient injury as a result of this issue.”
TruSignal sensors continuously monitor the amount of oxygen found in the blood flowing through the arteries and pulse rate. Placed on the skin, the sensors help to ensure that patients have enough oxygen in their blood to continue functioning. They also help care providers garner the information necessary to make treatment decisions.
Why GE HealthCare recalled the sensors
GE HealthCare recalled malfunctioning TruSignal sensors that may reduce the amount of energy sent to the heart during defibrillation. This issue occurs without any notification to the care provider. Without notification, this could prevent the delivery of lifesaving therapy in a critical situation.
The recall proves 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. They could provide inaccurate measurements of SpO2, impacting treatment decisions, too.
According to the FDA notice, the use of defective sensors may cause serious injury or death. GE HealthCare received four reports of injuries and no reports of death related to the issue. The FDA updated the notice to show that GE HealthCare received zero reports of injuries or death.
The company’s urgent medical device correction recommended that users find an alternate method for SpO2 monitoring. This could include unimpacted TruSignal sensors or an alternate device. If alternatives are unavailable, customers can use affected sensors as long as they have not been saturated with fluids.
In instances in which defibrillation is necessary when affected sensors are used, customers are urged to remove the affected sensor. They should defibrillate per hospital protocol and reattach the affected sensor once they don’t need defibrillation.
Specifically, for TruSignal adult/pediatric SpO2 sensors, customers should ensure they don’t have material covering the emitter or detector. They should discard the sensor and use another sensor if they find additional material present.
