ESAOTE recalls MyLab Alpha 7400 ultrasound probes due to potential overheating during 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 Alpha 7400 ultrasound probes because improper power monitoring settings can cause the probe head to overheat within a minute of continuous use, leading to discomfort and skin irritation. No injuries have been reported from this issue.
The probe's power monitoring settings may not work correctly under certain conditions, causing the probe head to overheat quickly. This overheating can lead to discomfort, redness, and mild pain on the skin where the probe is applied.
Patients using the MyLab Alpha 7400 ultrasound probes with the specific model number 7400 are affected. Healthcare providers using these probes for medical imaging are most at risk.
Check for the MyLab Alpha 7400 model number on the probe. This recall applies to the specific device model listed in the recall notice.
Look for the model number 7400 on the probe to confirm if it is affected.
No patient injuries have been reported with this issue.
Check for the model number 7400 on the probe.
The recall does not specify a remedy, so contact ESAOTE for further instructions.
We’ve drafted a message you can send ESAOTE to request your refund or repair — edit it as you like.
Subject: Recall Z-0204-2019 — ESAOTE ESAOTE Hello, I own a ESAOTE that is covered by recall Z-0204-2019 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.
