SEDECAL SM-32HF-Batt Mobile X-ray System: 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's mobile X-ray system model SM-32HF-Batt is recalled because it is not water-resistant. Improper cleaning could cause damage if not followed exactly as in the manual. This affects specific units with listed serial numbers.

Why it’s dangerous

The system is not designed to be water-resistant. If cleaned improperly, it could become damaged or malfunction. This risk is mitigated by following the manual's cleaning instructions exactly.

Who’s affected

Users of SEDECAL's mobile X-ray system model SM-32HF-Batt with the listed serial numbers. Medical facilities using this equipment are most at risk if they don't follow cleaning instructions.

How to tell if you have this one

Check for the model SM-32HF-Batt with the specific serial numbers listed in the recall notice. The equipment is a 32KW analog mobile X-ray system.

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 system is not water-resistant and must be cleaned strictly according to the manual to prevent damage.

What should I do if I have this model?

Check if your unit has the listed serial numbers; follow cleaning instructions in the manual to avoid damage.

Is there a fix or replacement available?

The recall does not mention a fix or replacement; users must follow cleaning instructions 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-0256-2026 — SEDECAL SEDECAL

Hello,

I own a SEDECAL that is covered by recall Z-0256-2026 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-0256-2026 (June 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0256-2026 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 SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system

Lower-risk recall