ESAOTE recalled 5 Endocavity Ultrasonic Probe E 3-12 units sold in the United States to healthcare providers in NC and TX. A potential weakness in the probe body could cause liquid to leak from the terminal part of the casing near the cable. Healthcare providers and patients should stop using the device immediately and follow manufacturer instructions.
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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The ESAOTE Endocavity Ultrasonic Probe E 3-12 is used in ultrasound imaging with endocavity applications. Healthcare facilities rely on these probes for diagnostic procedures.
A weakness in the probe body can allow liquid to leak from the terminal area near the cable. Liquid exposure can pose electrical and chemical risks during use.
This recall is not described as part of a broader industry pattern in the provided data.
Only 5 units were involved with US distribution in NC and TX. The risk is contingent on usage and exposure to the leaked liquid.
Recall notices are available through ESAOTE and the FDA enforcement page linked in the recall notice.
Typical recall remediation timelines vary; hospitals usually process replacements within weeks. The data does not specify exact timing for refunds or替
Keep recall notice, serial numbers, UDI, and all correspondence. Document the steps taken to remove affected devices from service.
Model: E 3-12 Reference: REF 120000038 UDI: 0805604453891 Serial numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C Where sold: United States, nationwide with distribution to NC and TX When sold: Recall dated 2025-03-14 Estimated quantity: 5 units Price: Unknown
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