The Recall Desk
HighFDA (Devices)·Z-1331-2022·Announced 2022-07-13

Omnera 400T Radiographic System Recalled for Potential Overhead Crane Malfunction

Arcoma AB is recalling 71 Omnera 400T radiographic systems because liquid ingress in the display handles may cause electrical short circuits and 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: FDA Class II medical device constituting a risk-of-harm product (X-ray system with overhead crane component). Hazard is theoretical with no reported illnesses or injuries, meeting the rubric criterion for High severity.

Plain-English summary

Arcoma AB is recalling 71 Omnera 400T Digital Radiographic Systems distributed nationwide throughout the United States and Canada. These are X-ray imaging systems used in medical facilities.

The recalled systems may develop an electrical short circuit due to liquid ingress in the display handles. This short circuit may cause uncontrolled movement of the Overhead Tube Crane (OTC), a component of the radiographic system.

Customers who own a recalled system should stop using the equipment immediately and contact Arcoma AB for repair or replacement instructions. The recalled systems can be identified by their UDI/DI codes and serial number ranges.

The recalled product

Product
Omnera 400T Digital Radiographic System
Manufacturer
Arcoma AB
Category
Medical Device — Diagnostic Imaging Equipment
Hazard
Affected units
71

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:07350008750050
  • 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 →

Related recalls

Same manufacturer · Arcoma AB

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Same hazard · short circuit

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