SEDECAL SM-40HF-B-D-C Mobile X-ray System: Not Water-Resistant

Take action

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 with model number SM-40HF-B-D-C because they are not water-resistant. If cleaned improperly, this could cause damage to the equipment.

Why it’s dangerous

The equipment is not water-resistant and must be cleaned strictly according to the manual. Improper cleaning could lead to equipment damage but does not pose a direct safety risk to users.

Who’s affected

Mobile X-ray system users who own the recalled model SM-40HF-B-D-C. Healthcare professionals using these systems are most at risk if they clean them incorrectly.

How to tell if you have this one

Check for model number SM-40HF-B-D-C on the device. The serial numbers listed are G39822, G62662, G62564, G61702, G60067, G38060.

Brand
SEDECAL
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Follow Cleaning Instructions
Clean the mobile X-ray system strictly according to the manual to avoid damage.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

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

What model numbers are affected?

Model number SM-40HF-B-D-C with serial numbers G39822, G62662, G62564, G61702, G60067, G38060.

Is there a fix or remedy for this issue?

The official notice does not provide a remedy; 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-0274-2026 — SEDECAL SEDECAL

Hello,

I own a SEDECAL that is covered by recall Z-0274-2026 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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-0274-2026 (June 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0274-2026 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 80C, Mobile X-ray system

Lower-risk recall