Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MyLab Seven Recalled by ESAOTE S.P.A. Due to The probe power monitoring settings have been found...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ESAOTE S.P.A. directly.
Affected Products
MyLab Seven, Model 6400
Quantity: 10
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ESAOTE S.P.A.
ESAOTE S.P.A. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report