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

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

SEDECAL's Model 40KWMOBILE3.899 mobile X-ray systems are not water-resistant and require strict cleaning per the manual. Improper cleaning could cause damage to the equipment.

Why it’s dangerous

The mobile X-ray system is not designed to be water-resistant. If cleaned improperly, it could become damaged or malfunction. This could affect the equipment's performance and safety.

Who’s affected

Users of SEDECAL's Model 40KWMOBILE3.899 mobile X-ray systems with serial numbers starting with G64852 are affected. Medical facilities using this equipment are most at risk.

How to tell if you have this one

Check for the model number 40KWMOBILE3.899 and serial numbers starting with G64852 on the equipment. This mobile X-ray system was sold by SEDECAL SA.

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 to the mobile X-ray system.

✎ GovInfoNow

Questions people ask

Is this product water-resistant?

No, the mobile X-ray system is not water-resistant and must be cleaned strictly according to the manual.

What should I do if I have this product?

Follow the cleaning instructions in the manual to prevent damage. The recall does not require stopping use.

How can I check if my product is affected?

Look for the model number 40KWMOBILE3.899 and serial numbers starting with G64852.

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-0253-2026 — SEDECAL SEDECAL

Hello,

I own a SEDECAL that is covered by recall Z-0253-2026 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-0253-2026 (June 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0253-2026 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 40KWMOBILE3.899, Mobile X-ray system

Lower-risk recall