GE Healthcare recalls specific GE LOGIQ E10 ultrasound systems due to potential overheating of trans-esophageal probes causing burn injuries. Affected units have serial numbers listed in the recall notice.
There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury.
GE Healthcare is recalling certain GE LOGIQ E10 ultrasound systems because the trans-esophageal (TEE) probe may overheat, leading to a burn injury risk. This is a serious hazard that requires immediate attention to prevent potential harm.
The trans-esophageal probe can overheat during use, which may cause a burn injury to the patient's esophagus. This overheating condition is undetected by the device's safety mechanisms, meaning the risk occurs without warning.
Qualified medical professionals who use the GE LOGIQ E10 ultrasound system for procedures involving trans-esophageal imaging are affected. Patients undergoing such procedures with the recalled units are at risk of burn injury.
Check if your GE LOGIQ E10 ultrasound system has a serial number listed in the provided list (e.g., 500055US7, 500022US7, etc.). The device is used by qualified physicians for specific medical imaging procedures.
Immediately stop using the affected GE LOGIQ E10 ultrasound system with the listed serial numbers to prevent potential burn injury.
The recalled model is GE LOGIQ E10 Ultrasound System with serial numbers listed in the recall notice (e.g., 500055US7, 500022US7, etc.).
Check the serial number on your device against the list of affected serial numbers provided in the recall notice.
The recall notice does not mention any remedy or replacement options; the device must be stopped from use immediately.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0588-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0588-2019 from GE Healthcare. 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.
