ESAOTE recalls MyLab Seven Model 6400 ultrasound probes due to overheating risk during prolonged use, causing discomfort and skin irritation. No injuries reported.
The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe power monitoring settings may not be effective in specific operating conditions so that the surface of the probe head may overheat in around one minute of continuous operations. The patient may experience discomfort, reddening of epidermis and/or mild pain. To date, no patient injury has been reported with regards to this issue.
ESAOTE is recalling its MyLab Seven ultrasound probes (Model 6400) because they can overheat during continuous use, potentially causing skin discomfort or mild pain. No injuries have been reported from this issue.
The probe's power monitoring settings may not work properly under certain conditions, causing the probe head to overheat after about one minute of continuous use. This overheating can lead to skin discomfort, redness, and mild pain for the patient.
Medical professionals using the MyLab Seven ultrasound system with the Model 6400 probe are most at risk. Patients receiving scans with this specific probe may experience discomfort or mild skin irritation.
Check if you own the MyLab Seven ultrasound system with the Model 6400 probe. The product was sold as part of the MyLab Seven system.
Identify if your probe is the MyLab Seven Model 6400 by checking the product label.
No patient injuries have been reported with this issue.
The affected probe is the MyLab Seven Model 6400. Check the product label for the model number.
The recall does not specify a remedy, so no action is required at this time.
We’ve drafted a message you can send ESAOTE to request your refund or repair — edit it as you like.
Subject: Recall Z-0206-2019 — ESAOTE ESAOTE Hello, I own a ESAOTE that is covered by recall Z-0206-2019 from ESAOTE. 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.
