GE Healthcare Finland recalls TruSignal AllFit Sensors (REF TS-AF-10 and AF-25) due to potential reduction in defibrillation energy reaching patients, which could affect safety during cardiac emergencies.
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 AllFit Sensors (REF TS-AF-10 and AF-25) because they might not deliver enough energy during defibrillation, risking inadequate treatment for cardiac emergencies. This could lead to serious complications if the device is used incorrectly.
The sensors may reduce the energy delivered during defibrillation, potentially leading to ineffective treatment of life-threatening cardiac arrhythmias. This could result in inadequate cardiac rhythm correction and increase the risk of complications during emergencies.
Healthcare providers using these sensors for defibrillation in medical settings are most at risk, particularly those in emergency care or cardiac monitoring.
Check for the REF TS-AF-10 (10 units) or REF AF-25 (25 units) labels on the sensors. The GTIN numbers 0840682103176 are also associated with these models.
Look for the REF TS-AF-10 (10 units) or REF AF-25 (25 units) labels on the sensors.
The sensors may reduce the energy delivered during defibrillation, potentially leading to ineffective treatment of cardiac emergencies.
Check for the REF TS-AF-10 (10 units) or REF AF-25 (25 units) labels on the sensors, or GTIN 0840682103176.
The recall does not specify an immediate stop; however, healthcare providers should verify the device model and consider the potential risk before use.
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-2027-2023 — GE Healthcare Finland GE Healthcare Finland Hello, I own a GE Healthcare Finland that is covered by recall Z-2027-2023 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.
