ESAOTE recalls MyLab Gamma 7410 ultrasound probes due to overheating risk during prolonged use. No injuries reported but discomfort and skin irritation possible.
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 Gamma 7410 ultrasound probes because improper power settings can cause the probe head to overheat within a minute of continuous use. This may lead to discomfort, redness, or mild pain for patients. No injuries have been reported so far.
The probe's power monitoring settings may not work properly under certain conditions, causing the probe head to overheat within about one minute of continuous operation. This overheating can lead to patient discomfort, redness, or mild pain without causing serious injury.
Patients using the MyLab Gamma 7410 ultrasound probe with ESAOTE may experience discomfort or skin irritation if the probe overheats during prolonged use. Healthcare providers using this specific model are most at risk.
Check if you own the MyLab Gamma ultrasound probe model 7410 from ESAOTE. This product was sold under the brand name ESAOTE.
Identify if your ultrasound probe is the MyLab Gamma model 7410 from ESAOTE.
No patient injuries have been reported with this issue, but discomfort and skin irritation may occur.
Look for the MyLab Gamma model 7410 from ESAOTE. This specific model has the power monitoring issue.
The recall record does not specify a remedy, so contact ESAOTE directly for guidance.
We’ve drafted a message you can send ESAOTE to request your refund or repair — edit it as you like.
Subject: Recall Z-0205-2019 — ESAOTE ESAOTE Hello, I own a ESAOTE that is covered by recall Z-0205-2019 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.
