GE Healthcare Finland recalls TruSignal Integrated Ear Sensors with Datex Connector (REF TS-E4-GE) due to potential defibrillation energy reduction and inaccurate measurements. Affected units sold with arrhythmia monitors.
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
GE Healthcare Finland is recalling Tru:Signal Integrated Ear Sensors with Datex Connector (REF TS-E4-GE) because they may not deliver proper defibrillation energy or cause inaccurate heart rhythm measurements. This could lead to incorrect treatment decisions during cardiac emergencies.
The ear sensor may not deliver sufficient energy during defibrillation, potentially failing to treat life-threatening heart rhythms. It could also cause inaccurate heart rhythm readings, leading to incorrect medical decisions.
Healthcare providers using the TruSignal ear sensor with arrhythmia monitors are most at risk. Patients with cardiac conditions requiring continuous monitoring may also be affected.
Check for the model reference TS-E4-GE on the ear sensor. The product was sold with arrhythmia detection monitors and has the GTIN 00840682103428.
Look for the model reference TS-E4-GE on the ear sensor.
Contact GE Healthcare Finland for specific instructions on whether to stop using the sensor or get a replacement.
The recall states there is a potential reduction in defibrillation energy or inaccurate measurements, which could affect cardiac treatment decisions. However, the exact risk level is not specified.
Check for the model reference TS-E4-GE on the ear sensor. The product was sold with arrhythmia detection monitors and has the GTIN 00840682103428.
Contact GE Healthcare Finland for specific instructions on whether to stop using the sensor or get a replacement.
We’ve drafted a message you can send GE Healthcare Finland to request your refund or repair — edit it as you like.
Subject: Recall Z-2032-2023 — GE Healthcare Finland GE Healthcare Finland Hello, I own a GE Healthcare Finland that is covered by recall Z-2032-2023 from GE Healthcare Finland. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
