OMNERA 400T 0180Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07350008750050), received between Dec 21, 2017 and Dec 21, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Installation-Related Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 5, 2021Open, Classified

   There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).

   Z-1331-2022 · Root cause: Device Design · FDA record ↗

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.

• MalfunctionDec 21, 2017Installation-Related Problem; Installation-Related Problem

  HAPPENED DURING INSTALLATION. THE INSTALLER DID NOT FOLLOW THE INSTRUCTION AND LIFTED THE TABLE WITHOUT THE SAFETY CLAMP MOUNTED. THE TABLE TOP FELL DOWN. NO PERSON WAS INJURED.

  Patient problems: No Patient Involvement

  MAUDE report 7139207 ↗