QT Scanner 2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00852619008003), received between Oct 30, 2025 and Oct 30, 2025 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED FOR QTSCAN ON (B)(6) 2025 FOR EVALUATION OF A PALPABLE LUMP IN THE RIGHT BREAST. SHE REPORTED FEELING A LUMP FOR 3 WEEKS AND THE TECHNICIAN FORM COMPLETED BY THE SCAN TECHNOLOGIST AT THE CLINIC INDICATED THAT THE LUMP WAS LOCATED AT THE 3 O'CLOCK POSITION, IN THE AREOLAR EDGE OF THE RIGHT BREAST. HOWEVER, SUBSEQUENT HANDHELD ULTRASOUND (HHUS) AND DIAGNOSTIC MAMMOGRAPHY PERFORMED AT ANOTHER FACILITY ON (B)(6) 2025, FOCUSED ATTENTION AT THE 10 O'CLOCK POSITION, WHICH THE REPORT FROM THE OUTSIDE FACILITY INDICATED WAS THE SITE OF THE PALPABLE LUMP DENOTED BY THE PATIENT. THE IMAGING REPORT FROM THE OUTSIDE FACILITY DESCRIBED A HIGHLY SUSPICIOUS MASS WITH RECOMMENDATION FOR AN ULTRASOUND-GUIDED CORE BIOPSY OF THE MASS IN THE RIGHT BREAST AT 10 O'CLOCK.

  Patient problems: Breast Mass

  MAUDE report 23433033 ↗