Use caution Medical device recall · FDA · Published May 5, 2021

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

Arcoma recalls Omnera 400A Digital Radiographic Systems from 2001-2003, 2006-2044, etc. due to liquid ingress causing short circuits that may move the overhead crane. Affected units have specific UDI/DI numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1332-2022Medical device Arcoma ›

Use caution until it’s fixed

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).

Take action

Contact the company

Recalling firmArcoma ABAnnavagen 1 · Vaxjo, Sweden

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/62600-arcoma-omnera-400a-x-ray-system-recall-liquid-short-circuit.

Source Summary by GovInfoNow · govinfonow.com/recall/62600-arcoma-omnera-400a-x-ray-system-recall-liquid-short-circuit · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1332-2022

Cite this page

“Arcoma Omnera 400A X-Ray System Recall: Liquid Short Circuit Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62600-arcoma-omnera-400a-x-ray-system-recall-liquid-short-circuit. Based on FDA recall #Z-1332-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1332-2022%22&limit=1).

Arcoma AB recalled Omnera 400A Digital Radiographic Systems due to potential short circuits from liquid ingress in display handles, which may cause uncontrolled movement of the Overhead Tube Crane, according to the FDA on May 5, 2021.

How to tell if you have it

Brand: Arcoma
Product: Omnera 400A Digital Radiographic System
UDI/DI: 07350008750012
Dates: 2001-2003, 2006-2044, 2046-2056, 2118-2126, 2128-2131, 2134-2160, 2164-2175, 2177-2195, 2197-2208, 2210-2212, 2214-2224, 2226-2236
Quantity: 47 systems

The hazard

The X-Ray system may short circuit due to liquid ingress in the display handles, potentially resulting in uncontrolled movement of the Overhead Tube Crane.

Context

GovInfoNow's records show other recent recalls of similar products include Canon Alphenix X-ray Systems Recall: Loose Fixing Screws Risk Equipment Failure (2026-08-04), Canon Alphenix INFX-8000C X-ray System Recall: Ceiling Movement May Become Unstable (2025-12-19), and GE Optima XR220amx Mobile X-Ray System Recall: Risk of Patient Injury (2026-06-05).

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

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
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.

Recall number	Product, codes & lots	Quantity
Z-1331-2022	Omnera 400T Digital Radiographic System; 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.	71 systems
Z-1332-2022	Omnera 400A Digital Radiographic System; 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.	47 systems

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.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 23 states.

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Arkansas, California, Colorado, Delaware, Florida, Illinois, Indiana, Louisiana, Michigan, Missouri, Nevada, New Mexico, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Vermont, Virginia, Washington.

Recall timeline

FDA published this recall 14 months after the firm started it.

May 5, 2021Firm started the recall
Jul 5, 2022FDA classified it Class II
Jul 13, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/62600-arcoma-omnera-400a-x-ray-system-recall-liquid-short-circuit">Arcoma Omnera 400A X-Ray System Recall: Liquid Short Circuit Risk (GovInfoNow)</a>

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.