SEDECAL Mobile X-ray System SM-40HF-B-D-C: 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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

SEDECAL is recalling mobile X-ray systems SM-40HF-B-D-C; 40KW.005 because they are not water-resistant. Improper cleaning could cause damage or safety issues if not followed correctly.

Why it’s dangerous

The equipment is not designed to be water-resistant. If cleaned improperly, it could lead to damage or safety hazards. Proper cleaning according to the manual is required to prevent issues.

Who’s affected

Healthcare facilities using these mobile X-ray systems are most likely affected. Users must follow cleaning instructions to avoid damage.

How to tell if you have this one

Check for model number SM-40HF-B-D-C; 40KW.005 on the device. Affected units have specific serial numbers: G64274, G40012, G64597, G70742, G72764, G61804.

Brand
SEDECAL
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Cleaning Instructions
Review the manual for proper cleaning procedures to avoid damage.

✎ GovInfoNow

Questions people ask

Why is this X-ray system being recalled?

The equipment is not water-resistant and must be cleaned strictly according to the manual to prevent damage or safety issues.

What model numbers are affected?

Model number SM-40HF-B-D-C; 40KW.005 with specific serial numbers: G64274, G40012, G64597, G70742, G72764, G61804.

Do I need to stop using the X-ray system?

No, but you must follow cleaning instructions carefully to avoid 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-0279-2026 — SEDECAL SEDECAL

Hello,

I own a SEDECAL that is covered by recall Z-0279-2026 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-0279-2026 (June 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0279-2026 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; 40KW.005, Mobile X-ray system

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