OMNERA 400A 0072Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07350008750012), received between Mar 12, 2018 and Mar 12, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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-1332-2022 · 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.

• MalfunctionMar 12, 2018Defective Component; Defective Component

  UNSTABLE AEC-EXPOSURES HAVE BEEN NOTED DURING CLINICAL USE AT A CHILDREN HOSPITAL. THE AVERAGE EXPOSURE INDEX HAS BEEN 3.5 TIMES LARGER THAN FOR SIMILAR SYSTEMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7330554 ↗