GE HealthCare is recalling 7559 TruSignal arterial oxygen saturation (SpO2) sensors because of problems that may reduce defibrillation energy, expose patients to unintended voltage, or give inaccurate readings.
The US Food and Drug Administration (FDA) has identified this as a class I recall, the most serious type. The company reports that there have been four injuries but no deaths related to these issues.
The recall includes the 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.
The sensors were distributed in the US from January 1, 2021, to March 4, 2023.
According to the recall notice, the malfunctioning 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. 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,” the notice warns.
In an urgent device correction letter sent to healthcare professionals in May, GE HealthCare recommends that healthcare professionals do the following:
Use an alternate method for SpO2 monitoring, including TruSignal sensors not impacted or an alternate SpO2 device.
If alternate methods are not available, use affected TruSignal SpO2 sensors as long as they have not been saturated with fluids.
If defibrillation is necessary when affected TruSignal SpO2 sensors are being used, remove the affected TruSignal SpO2 sensor, defibrillate per hospital protocol, and reattach the affected TruSignal SpO2 sensor after defibrillation is no longer needed.
For Adult/Pediatric SpO2 sensors, confirm that material does not cover the emitter or detector before using.
Discard the sensor and use another sensor if any additional material is present.
Make sure all potential users are made aware of this safety notification and the recommended actions, and retain this notice.
Customers are also asked to complete and return the acknowledgment form attached to the notice to [email protected].
For questions or concerns about this recall, contact GE HealthCare Service at 1-800-437-1171 or a local service representative.
Healthcare professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
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