SEDECAL SM-40HF-B-D-C 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 is recalling its SM-40HF-B-D-C mobile X-ray system because it is not water-resistant. If cleaned improperly, it could be damaged or cause safety issues. This affects medical facilities using the equipment.

Why it’s dangerous

The equipment is not water-resistant and must be cleaned per the manual. Improper cleaning could lead to damage or safety issues, but the hazard does not cause immediate injury.

Who’s affected

Medical facilities that own or use the SEDECAL SM-40HF-B-D-C mobile X-ray system. Staff and patients using the equipment are at risk if it gets wet.

How to tell if you have this one

Check for the model number SM-40HF-B-D-C and specific serial numbers listed in the recall notice. The equipment is a 40KW 50G mobile X-ray system.

Brand
SEDECAL
Category
Medical device

Based on the official FDA remedy

What to do — step by step

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

✎ GovInfoNow

Questions people ask

Is this product safe to use?

Yes, but it must be cleaned strictly according to the manual to prevent damage.

What happens if I don't follow the cleaning instructions?

Improper cleaning could cause damage to the equipment, but the recall does not mention injury risks.

How do I know if my unit is affected?

Check the serial numbers listed in the recall notice: G25456, G25508, and other specific numbers provided.

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-0258-2026 — SEDECAL SEDECAL

Hello,

I own a SEDECAL that is covered by recall Z-0258-2026 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-0258-2026 (June 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0258-2026 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 50G, Mobile X-ray system

Lower-risk recall