Arcoma Omnera 400A X-Ray System Recall: Liquid Short Circuit Risk

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Recalling firmArcoma ABAnnavagen 1, N/A · Vaxjo, N/A N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Arcoma is recalling Omnera 400A Digital Radiographic Systems that could short circuit from liquid entering the display handles. This might cause the overhead tube crane to move unexpectedly, posing a risk of injury.

Why it’s dangerous

Liquid can enter the display handles, causing a short circuit. This may lead to uncontrolled movement of the overhead tube crane, potentially causing injury to people nearby.

Who’s affected

Medical facilities using Omnera 400A systems from 2001-2003, 2006-2044, and other years listed in the recall. Staff handling the equipment are most at risk if the short circuit occurs.

How to tell if you have this one

Check for the UDI/DI number 07350008750012 on the system. The product was sold between 2001-2003, 2006-2044, and other specific years listed in the recall.

Brand
Arcoma
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Short Circuit
Inspect the display handles for signs of liquid ingress or damage.

✎ GovInfoNow

Questions people ask

What is the specific model number of the recalled system?

The Omnera 400A Digital Radiographic System with UDI/DI: 07350008750012.

When was this product sold?

From 2001-2003, 2006-2044, and other specific years listed in the recall.

How can I tell if my system is affected?

Check for the UDI/DI number 07350008750012 on the system. The product was sold during the listed years.

Take action

Contact Arcoma

We’ve drafted a message you can send Arcoma to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1332-2022 — Arcoma Arcoma

Hello,

I own a Arcoma that is covered by recall Z-1332-2022 from Arcoma.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1332-2022 (May 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1332-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Arcoma AB recalls Omnera 400A Digital Radiographic System

Use caution until it’s fixed