Arcoma recalls Omnera 400T Digital Radiographic Systems from 2001-2003, 2006-2044, and other years due to liquid ingress causing short circuits that could move the overhead crane. Affected units may need repair.
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).
Arcoma is recalling Omnera 400T Digital Radiographic Systems that could short circuit from liquid entering the display handles. This might cause the overhead tube crane to move unexpectedly, creating a safety hazard.
Liquid can enter the display handles, causing the X-ray system to short circuit. This may lead to uncontrolled movement of the overhead tube crane, potentially causing injury if the crane moves unexpectedly during use.
Medical facilities using Omnera 400T systems from 2001-2003, 2006-2044, and other years are most at risk. The hazard affects the equipment during normal operation in radiology settings.
Check for Omnera 400T Digital Radiographic Systems with UDI/DI:07350008750050. The product was sold from 2001-2003, 2006-2044, and other years as listed in the recall notice.
Inspect display handles for signs of liquid damage or corrosion.
Reach out to Arcoma AB for guidance on next steps and potential repairs.
Liquid can enter the display handles, causing the X-ray system to short circuit and potentially move the overhead tube crane unexpectedly.
Contact Arcoma AB for guidance on next steps and potential repairs. The recall does not require immediate shutdown.
The Omnera 400T was sold from 2001-2003, 2006-2044, and other years as listed in the recall notice.
We’ve drafted a message you can send Arcoma to request your refund or repair — edit it as you like.
Subject: Recall Z-1331-2022 — Arcoma Arcoma Hello, I own a Arcoma that is covered by recall Z-1331-2022 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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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.