FDA Adverse Event Injury Summary report: N

TRANSDUCER, ULTRASONIC, DIAGNOSTIC

MDR report key: 23166051 · Received September 29, 2025

Report

Report Number
MW5176662
Event Type
Injury
Date Received
September 29, 2025
Report Date
September 9, 2025
Manufacturer
QT IMAGING, INC.
Product Code
ITX
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

THIS IS REGARDING QT (QUANTITATIVE TRANSMISSION) IMAGING PERFORMED AT THE (B)(6) IN (B)(6). I DO NOT HAVE THE MODEL, LOT NUMBER, OR ANY DEVICE IDENTIFIER. I AM A BREAST IMAGING RADIOLOGIST AT A BREAST CENTER AND HAVE A CASE IN WHICH A PATIENT HAD A NORMAL QT SCAN INTERPRETATION. SHE DID FEEL A LUMP, AND THE REPORT FROM QT SCAN SAID TO DO AN ULTRASOUND IF INDICATED OR A FOLLOW UP QT SCAN IN 3-4 MONTHS. IT SAID NOTHING ABOUT DOING A MAMMOGRAM. LUCKILY THIS PATIENT DID HAVE APPROPRIATE IMAGING AND WAS FOUND TO HAVE A 2.5 CM BREAST CANCER (WHICH THE QT SCAN SAID THAT NO MALIGNANCY PRESENT). THIS COMPANY HAS FALSE ADVERTISING AND SAYS THAT IT IS BETTER THAN TRADITIONAL ULTRASOUND AND MAMMOGRAPHY. YET IT DID NOT FIND THE CANCER. LUCKILY THIS PATIENT DID HAVE A LUMP AND HER DOCTOR WANTED HER TO HAVE IT LOOKED AT WITH MAMMOGRAPHY AND TRADITIONAL BREAST ULTRASOUND. IT'S WEBSITE PUTS DOWN MAMMOGRAPHY AND TRADITIONAL BREAST ULTRASOUND, IMPLYING THAT IT HAS BETTER TECHNOLOGY. IT ALSO SAYS THAT QT DOES NOT RUPTURE IMPLANTS, WHICH IMPLIES THAT OTHER TECHNOLOGIES CAN RUPTURE IMPLANTS (FALSE). IT TALKS OF THE "HARMS" OF MAMMOGRAPHY AND RADIATION, HARMS OF CONTRAST (WHICH IMPLIES THAT BREAST MRI IS ALSO BAD). WOMEN WHO GET THIS QT SCAN OR GETTING THE IMPRESSION THAT EVERYTHING IS OK WITH JUST THAT TYPE OF IMAGING. FURTHERMORE, THEY ARE WALKING AWAY WITH THE IMPRESSION THAT THIS EXAM IS BETTER THAN MAMMOGRAPHY, TRADITIONAL BREAST ULTRASOUND, AND BREAST MRI...AND THAT THEY DON'T NEED THE TRADITIONAL BREAST IMAGING (WHICH IS PROVEN TO FIND CANCERS). ADDITIONALLY, DENSE BREAST TISSUE IS ONLY DEFINED ON MAMMOGRAPHY, SO WOMEN WHO NEVER GET A MAMMOGRAM WON'T REALLY KNOW THEIR TISSUE TYPE. I HAVE SEEN CASES NOW IN WHICH A LARGE CANCER WAS MISSED ON QT SCAN, A "3 CM MASS" ON QT SCAN WAS ACTUALLY JUST NORMAL TISSUE ON TRADITIONAL BREAST IMAGING, AND A CASE IN WHICH QT SCAN FOUND ONLY 1 MASS FOR WHICH THE PATIENT WAS SENT TO US FOR EVALUATION HOWEVER THAT PATIENT ACTUALLY HAD MULTIPLE MASSES WHICH HAD BEEN FOLLOWED FOR YEARS AND WERE PROVEN BENIGN ALREADY DUE TO MULTI-YEAR STABILITY. THIS TECHNOLOGY GIVES WOMEN FALSE REASSURANCE THAT EVERYTHING IS OKAY AND BASICALLY GIVING WOMEN THE NOTION THAT MAMMOGRAPHY IS NOT NEEDED, AND TRADITIONAL BREAST ULTRASOUND AND BREAST MRI ARE WORTHLESS. HIGH RISK WOMEN ARE BASICALLY BEING TOLD THAT QT IMAGING IS BETTER THAN BREAST MRI, WHICH IS FALSE AS BREAST MRI IS THE MOST SENSITIVE PROVEN IMAGING TOOL FOR FINDING BREAST CANCERS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1796688 TRANSDUCER, ULTRASONIC, DIAGNOSTIC TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX QT IMAGING, INC.

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown