Arcoma AB recalls Omnera 400A Digital Radiographic System

Recall date

May 5, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1332-2022

FDA classification

Class II

Brand / firm

Arcoma AB

Sold / distributed

US Nationwide distribution in the states of NM, DE, TX, VT, FL, MO, UT, PA, OR, IN, RI, MI, IL, LA, OH, CO, SC, VA, WA, CA, AZ, NV, AR and the country of Canada.

Why it was 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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Omnera 400A Digital Radiographic System