InnoSight Diagnostic Ultrasound System 989605463521Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04719873000012), received between May 20, 2025 and May 20, 2025 — classified as 1 death.

The most frequently reported specific device problem is “Poor Quality Image” (1 report).

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 18, 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.

• DeathMay 20, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT A THROMBUS WAS NOT VISUALIZED ON THE INNOSIGHT ULTRASOUND SYSTEM DURING A PORTABLE FOCUSED ECHO SCAN AND PATHOLOGY. A REPEAT ECHO WAS PERFORMED AT A LATER DATE USING A DIFFERENT SYSTEM. THE THROMBUS WAS VISUALIZED. THE PATIENT RECEIVED A BONE MARROW TRANSPLANT AND SUBSEQUENTLY DIED. AN INTERNAL SITE INVESTIGATION IS CURRENTLY UNDERWAY TO DETERMINE WHETHER THE LACK OF VISUALIZATION OF THE SUBSTRATE CONTRIBUTED TO CAUSE OF DEATH. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Insufficient Information

  MAUDE report 22052180 ↗