A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.
A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ESAOTE S.P.A. or your healthcare provider for instructions. Notification method: Letter
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Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038. Reason: A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.. Classification: Class II. Quantity: 5 units. Distribution: US: Nationwide distribution in the states of NC and TX.
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Stability Data Does Not Support Expiry Date.
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