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.
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 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
- Hazard
- defibrillation-failure
- electrical-hazard
- measurement-error
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.
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