GE Healthcare Finland recalls TruSignal Adult/Pediatric Ear Oximeters (REF TS-AP-10 and TS-AP-25) due to potential reduction in defibrillation energy reaching patients during cardiac events.
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
GE Healthcare Finland is recalling two models of ear oximeters because they might not deliver enough defibrillation energy during cardiac emergencies, which could be life-threatening. This recall affects medical devices used for monitoring oxygen levels in patients.
The ear oximeters may reduce the energy delivered during defibrillation, potentially causing cardiac events to fail to be treated effectively. This could lead to inaccurate oxygen measurements or unintended electrical contact during medical procedures.
Healthcare providers using these ear oximeters for patient monitoring are most at risk, particularly in emergency settings where defibrillation is needed.
Check for the model numbers REF TS-AP-10 (10 units) or REF TS-AP-25 (25 units) on the device packaging or label. These oximeters were sold with the same GTIN numbers 00840682103220 for both models.
Identify if your ear oximeter has model numbers REF TS-AP-10 or REF TS-AP-25.
The recall is due to a potential reduction in energy reaching patients during defibrillation, which could affect cardiac emergency treatment.
These devices may not deliver sufficient defibrillation energy during cardiac events, which could lead to ineffective treatment of life-threatening conditions.
The recall record does not specify a remedy, so contact GE Healthcare Finland for further instructions.
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-2026-2023 — GE Healthcare Finland GE Healthcare Finland Hello, I own a GE Healthcare Finland that is covered by recall Z-2026-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
