Agency classClass IOur severity:Severe FDA (Devices)·Z-2033-2023·Announced 2023-07-12

GE TruSignal Ear Sensor Oximeter Recalled for Defibrillation Energy and Voltage Hazards

GE Healthcare is recalling 708 TruSignal Integrated Ear Sensors (medical-grade pulse oximeters) due to potential defects that could reduce defibrillation energy, cause electrical shock, or produce 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 severity rubric, FDA Class I recalls require a minimum score of 4 (Severe). The identified hazards—potential defibrillation failure, electrical shock risk, and measurement inaccuracy—directly threaten patient safety in critical clinical situations.

Plain-English summary

GE Healthcare Finland Oy is recalling the TruSignal Integrated Ear Sensor with Datex Connector (model REF TS-E4-N), a medical-grade pulse oximeter used in clinical settings. The recall affects approximately 708 devices distributed worldwide.

The devices may pose three distinct patient safety hazards: potential reduction of energy delivery during defibrillation therapy, potential contact with unintended electrical voltage, and inaccurate oxygen saturation measurements. These defects were identified through an FDA Class I recall mechanism, indicating serious patient safety concern.

Healthcare facilities and clinical staff using these devices are affected. Any patient who may receive care involving this oximeter could be exposed to these hazards.

Healthcare providers should immediately discontinue use of any TruSignal Integrated Ear Sensors matching the recalled model (REF TS-E4-N, GTIN 00840682103381). Contact GE Healthcare directly for instructions on device replacement or return, and review any patient records for individuals who may have received care with affected devices.

The recalled product

Product: TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter
Manufacturer: GE Healthcare Finland Oy
Category: Medical Device — Patient Monitoring / Pulse Oximeter
Hazard: defibrillation-failure
electrical-hazard
measurement-error
Affected units: 708

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 00840682103381

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 failure