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U.S. Department of Health and Human Services

Class 2 Device Recall Esaote

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 Class 2 Device Recall Esaotesee related information
Date Initiated by FirmMarch 14, 2025
Date PostedMarch 03, 2026
Recall Status1 Completed
Recall NumberZ-1490-2026
Recall Event ID 98339
510(K)NumberK230179 
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
ProductEsaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Code Information UDI 0805604453891, Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C.
FEI Number 3012981490
Recalling Firm/
Manufacturer		 ESAOTE S.P.A.
Sesto Fiorentino
Via Degli Olmi 11
Sesto Fiorentino Italy
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Process control
ActionEsaote issued a Field Safety Notice to its consignees on 3/14/2025 via FedEx. The notice explained the problem with the device, potential risk of use and requested the following: "Actions to be performed by the user " If the operator detects the issue during the inspection, they must NOT use the probe and should contact Esaote's technical support. " Please distribute this Safety Notice to all personnel involved within your organization and to all users of the device. " If the device is no longer in your possession, please provide Esaote with the new owner's details or inform us about the current status of the device. As a precautionary measure, and to complete the root cause analysis while improving our processes and customer service, Esaote will proceed with a voluntary precautionary recall. Our Technical Support Service will soon contact customers who own the affected units to arrange for the replacement of the probe."
Quantity in Commerce5 units
DistributionUS: Nationwide distribution in the states of NC and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database510(K)s with Product Code = ITX
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