GE TruSignal Ear Sensor recalled for defibrillation, voltage, and measurement risks
GE Healthcare is recalling 2,707 TruSignal Integrated Ear Sensors (GTIN 00840682103428) worldwide due to potential reduced defibrillation energy delivery, unintended voltage exposure, and inaccurate measurements.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Per the rubric, FDA Class I recalls must have a minimum severity score of 4 (Severe), regardless of whether injuries have been reported. The hazards described—defibrillation energy reduction, unintended voltage contact, and inaccurate measurement—present serious risks during critical patient care.
Plain-English summary
GE Healthcare Finland Oy is recalling 2,707 units of the TruSignal Integrated Ear Sensor with Datex Connector (REF TS-E4-GE), a physiological monitor with arrhythmia detection, worldwide. The device is identified by GTIN 00840682103428.
The sensor may experience a potential reduction of energy reaching the patient during defibrillation, potential contact with unintended voltage, or provide inaccurate measurements.
Patients and healthcare providers currently using this device should discontinue use and contact GE Healthcare Finland Oy for information regarding replacement or repair options.
The recalled product
- Product
- TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
- Manufacturer
- GE Healthcare Finland Oy
- Hazard
- defibrillation-energy-reduction
- unintended-voltage
- inaccurate-measurement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN 00840682103428
Distribution
Distribution scope not specified by the agency.
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