Medical Oximeter Sensor Recalled Due to Defibrillation Energy and Voltage Hazards
GE Healthcare is recalling 237 TruSignal Integrated Ear Sensors worldwide due to potential failures in defibrillation energy delivery, unintended voltage contact, and measurement inaccuracy.
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: FDA Class I classification requires a minimum severity score of 4. The hazard of reduced defibrillation energy poses significant risk to patients during cardiac emergencies, and unintended voltage contact poses electrical injury risk. No deaths or serious injuries are reported, which prevents a Critical (5) rating.
Plain-English summary
GE Healthcare Finland Oy is recalling 237 TruSignal Integrated Ear Sensors with Ohmeda Connector (REF TS-E4-H) distributed worldwide. The FDA has classified this as a Class I recall.
The recalled sensors may experience three hazards: reduction in energy reaching the patient during defibrillation, potential contact with unintended voltage, and inaccurate measurement. These defects could prevent the device from functioning properly during critical patient care, including cardiac emergency treatment.
Healthcare providers and patients using this device should contact GE Healthcare for replacement units and stop using affected sensors in clinical settings. Report any harm to the FDA's MedWatch program at (888) 438-7999 or online.
The recalled product
- Product
- TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
- Manufacturer
- GE Healthcare Finland Oy
- Affected units
- 237
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 00840682103367
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.
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