High FDA (Devices)·Z-1332-2022·Announced 2022-07-13

Omnera 400A Digital Radiographic System: Electrical Short Circuit Hazard

Arcoma AB recalls 47 Omnera 400A Digital Radiographic Systems due to potential electrical short circuits that could cause uncontrolled movement of the overhead tube crane.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall for a potential hazard that could cause uncontrolled equipment movement. No illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product without reported adverse events, warranting a High (Score 3) severity.

Plain-English summary

Arcoma AB is recalling the Omnera 400A Digital Radiographic System, a medical imaging device used in healthcare settings. A total of 47 systems have been identified in this recall.

The recall addresses a potential safety hazard in which liquid may enter the display handles, potentially causing an electrical short circuit. If this occurs, it could result in uncontrolled movement of the Overhead Tube Crane (OTC), the motorized arm that positions the X-ray tube.

The affected systems were distributed nationwide across 23 U.S. states and Canada. Facilities with affected units should contact Arcoma AB or the FDA for recall information.

The recalled product

Product: Omnera 400A Digital Radiographic System
Manufacturer: Arcoma AB
Category: Medical Device — Radiology / Digital Radiographic System
Hazard: electrical-short
uncontrolled-movement
Affected units: 47

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

UDI/DI: 07350008750012
2001-2003
2006-2044
2046-2056
2118-2126
2128-2131
2134-2160
2164-2175
2177-2195
2197-2208
2210-2212
2214-2224
2226-2236.

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Arcoma AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Arcoma AB

See all →

High
Omnera 400T Radiographic System Recalled for Potential Overhead Crane Malfunction
FDA (Devices) · 2022-07-13

Same hazard · electrical short