Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Omnera 400T Digital Radiographic System Recalled by Arcoma AB Due to There is the potential for the X-Ray system...

Date: May 5, 2021
Company: Arcoma AB
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Arcoma AB directly.

Affected Products

Omnera 400T Digital Radiographic System

Quantity: 71 systems

Why Was This Recalled?

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).

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Arcoma AB

Arcoma AB has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report