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 mobile X-ray systems with model number SM-40HF-B-D-C due to a lack of water resistance. If cleaned improperly, these devices could be damaged or malfunction.

Why it’s dangerous

The mobile X-ray system is not water-resistant and must be cleaned strictly according to the manual. Improper cleaning could cause damage or malfunction, but the hazard does not involve immediate safety risks like injury or fire.

Who’s affected

Healthcare facilities using the mobile X-ray system are most likely affected. Patients and staff using the equipment without proper cleaning could face device damage.

How to tell if you have this one

Check for model number SM-40HF-B-D-C on the device. Affected units have serial numbers listed in the recall notice, including G65281, G60407, and others.

Brand
SEDECAL
Category
Medical device

Based on the official FDA remedy

What to do — step by step

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

✎ GovInfoNow

Questions people ask

Is this X-ray system safe to use?

Yes, but it must be cleaned according to the manual to prevent damage. Improper cleaning could cause malfunction.

What happens if I clean it incorrectly?

The device could be damaged or malfunction, but the recall does not mention injury risks.

How do I know if my unit is affected?

Check the model number SM-40HF-B-D-C and serial numbers listed in the recall notice.

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-0277-2026 — SEDECAL SEDECAL

Hello,

I own a SEDECAL that is covered by recall Z-0277-2026 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-0277-2026 (June 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0277-2026 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, Mobile X-ray system

Lower-risk recall