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 its mobile X-ray system model SM-40HF-B-D-C because it is not water-resistant. Using it without proper cleaning could cause damage or safety issues.

Why it’s dangerous

The system is not water-resistant and must be cleaned strictly per the manual. Improper cleaning could lead to damage or safety issues.

Who’s affected

Medical facilities using this mobile X-ray system are likely affected. Users with improper cleaning practices face the highest risk.

How to tell if you have this one

Check for model number SM-40HF-B-D-C on the device. The system is a 40KW 55C/60C mobile X-ray system with serial number G33585.

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 or safety issues.

✎ GovInfoNow

Questions people ask

Is this X-ray system water-resistant?

No, the system is not water-resistant and requires strict cleaning per the manual.

What should I do if I have this X-ray system?

Follow the cleaning instructions in the manual to prevent damage or safety issues.

Is there a fix or replacement available?

The recall record does not mention a fix or replacement.

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-0266-2026 — SEDECAL SEDECAL

Hello,

I own a SEDECAL that is covered by recall Z-0266-2026 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-0266-2026 (June 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0266-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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 55C/60C, Mobile X-ray system

Lower-risk recall