Agency classClass IOur severity:Severe FDA (Devices)·Z-2032-2023·Announced 2023-07-12

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Category: Medical Device — Physiological Monitoring
Hazard: defibrillation-energy-reduction
unintended-voltage
inaccurate-measurement
Affected units: 2,707

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.

Part of a larger recall action

This product is one of 9 recalled by GE Healthcare Finland Oy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Same manufacturer · GE Healthcare Finland Oy

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Same hazard · defibrillation energy reduction