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
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained from the probes.
These labels are deterministic app interpretations, not FDA categories.
Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained from the probes.
Code information
UDI - Primary - 00861589000108 Lot numbers: 20250509 and 20250823
