GE Healthcare Finland recalls TruSignal Integrated Ear Sensors with Ohmeda Connector REF TS-E4-H due to potential defibrillation energy reduction and inaccurate measurements.
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
GE Healthcare Finland is recalling TruSignal Integrated Ear Sensors with Ohmed:4-H connector because they might not deliver enough energy during defibrillation or give inaccurate readings. This could affect patient safety during critical medical procedures.
The sensors might not deliver sufficient electrical energy during defibrillation, which could fail to restart a heart. They might also provide inaccurate oxygen measurements, leading to incorrect patient assessments.
Healthcare professionals using the TruSignal ear sensors for patient monitoring are most at risk, particularly during emergency defibrillation procedures.
Check for the model number REF TS-E4-H on the sensor or the GTIN 00840682103367 label. The product was sold with GE Healthcare Finland's medical devices.
Look for the model number REF TS-E4-H or GTIN 00840682103367 on the sensor packaging or device.
The recall is due to potential reduction in energy during defibrillation, contact with unintended voltage, or inaccurate measurements.
The recall record does not specify a remedy or fix.
The recall record does not specify contact information.
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-2034-2023 — GE Healthcare Finland GE Healthcare Finland Hello, I own a GE Healthcare Finland that is covered by recall Z-2034-2023 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.
