GE Healthcare Finland recalls TruSignal Ear Sensor REF TS-E-D for potential defibrillation energy reduction and inaccurate measurements. Affected units may pose risks during medical procedures.
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 Ear Sensors with model REF TS-E-D due to potential risks during defibrillation. This could lead to inaccurate measurements or reduced energy reaching the patient during critical medical procedures.
The device may not deliver sufficient energy during defibrillation, potentially causing treatment failure. It could also cause inaccurate blood oxygen readings or unintended electrical contact during use.
Medical professionals using the TruSignal Ear Sensor for defibrillation or oximetry are most at risk. Patients receiving care with this device may also be affected.
Check for the model number REF TS-E-D on the TruSignal Ear Sensor. The product was sold with GTIN 00840682103251.
Look for the model number REF TS-E-D on the TruSignal Ear Sensor.
The recall is due to potential reduction of energy reaching the patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
The recall record does not specify a remedy, so check with GE Healthcare Finland for further instructions.
The recall indicates potential risks during defibrillation, so use with caution until further instructions are received.
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-2030-2023 — GE Healthcare Finland GE Healthcare Finland Hello, I own a GE Healthcare Finland that is covered by recall Z-2030-2023 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.