SEDECAL Mobile X-ray System Recall: Not Water-Resistant

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Contact the company & request your remedy

Recalling firmSEDECAL SAPelaya, 9 Pol., Pol. Ind. Rio De Janeiro · Algete, N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

SEDECAL's mobile X-ray systems (model SM-40HF-B-D-C and 40KW70CDEMO.005) are recalled because they are not water-resistant. Improper cleaning could cause damage to the equipment.

Why it’s dangerous

The equipment is not water-resistant, so exposure to water or improper cleaning could damage it. This could lead to malfunction or failure to operate properly if not cleaned correctly.

Who’s affected

Users of SEDECAL mobile X-ray systems with the specified model numbers and serials are affected. Medical facilities using these systems are most at risk.

How to tell if you have this one

Check for model numbers SM-40HF-B-D-C or 40KW70CDEMO.005 and serial numbers G38652, G37633, G36042, G37641, 608A, or G36681. These systems were sold with UDI/DI 08436046001510.

Brand
SEDECAL
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model and Serial Numbers
Look for model numbers SM-40HF-B-D-C or 40KW70CDEMO.005 and serial numbers G38652, G37633, G36042, G37641, 608A, or G36681.

✎ GovInfoNow

Questions people ask

Why is this mobile X-ray system being recalled?

The equipment is not water-resistant and must be cleaned strictly according to the manual to avoid damage.

What model numbers are affected?

Model numbers SM-40HF-B-D-C and 40KW70CDEMO.005 with specific serial numbers.

Do I need to stop using this equipment?

No, but it must be cleaned strictly according to the manual to prevent damage.

Take action

Contact SEDECAL

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

✉️ Open in email

Subject: Recall Z-0280-2026 — SEDECAL SEDECAL

Hello,

I own a SEDECAL that is covered by recall Z-0280-2026 from SEDECAL.

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-0280-2026 (June 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0280-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.

SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system

Lower-risk recall