openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 1
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
UDI 0805604453891, Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C.
Distribution pattern
US: Nationwide distribution in the states of NC and TX.
