FDA Devices Moderate Class II Ongoing

Omnera 400A Digital Radiographic System

Reported: July 13, 2022 Initiated: May 5, 2021 #Z-1332-2022

Product Description

Reason for Recall

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).

Details

Recalling Firm: Arcoma AB
Units Affected: 47 systems
Distribution: 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.
Location: Vaxjo, N/A

Frequently Asked Questions

What product was recalled? ▼

Omnera 400A Digital Radiographic System. Recalled by Arcoma AB. Units affected: 47 systems.

Why was this product 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).

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on July 13, 2022. Severity: Moderate. Recall number: Z-1332-2022.