IMAGE1 PILOT TC014Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551387337), received between May 5, 2026 and May 5, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT ENCOUNTERED A MAJOR ISSUE THIS AFTERNOON WHILE USING THE VITOM 3D SYSTEM. THE PILOT BECAME UNRESPONSIVE. THE PATIENT WAS ALREADY OPENED AND UNDER ANESTHESIA, WHICH PLACED THE PATIENT AT SIGNIFICANT RISK. PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT DAMAGE, HOWEVER THERE WAS 1 HOUR DELAY. SINCE THE PATIENT ALREADY UNDER ANESTHESIA AND OPENED WITH DELAY OF 1 HOUR, THIS CASE IS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086707 ↗
• InjuryMay 5, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT ENCOUNTERED A MAJOR ISSUE THIS AFTERNOON WHILE USING THE VITOM 3D SYSTEM. THE PILOT BECAME UNRESPONSIVE. THE PATIENT WAS ALREADY OPENED AND UNDER ANESTHESIA, WHICH PLACED THE PATIENT AT SIGNIFICANT RISK. PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT DAMAGE, HOWEVER THERE WAS 1 HOUR DELAY. SINCE THE PATIENT ALREADY UNDER ANESTHESIA AND OPENED WITH DELAY OF 1 HOUR, THIS CASE IS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086691 ↗