SEDECAL Mobile X-ray System SM-40HF-B-D-C 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 is recalling its mobile X-ray system model SM-40HF-B-D-C because it is not water-resistant. Using it without proper cleaning could cause damage to the equipment. This recall affects specific units with the serial number G37528.

Why it’s dangerous

The mobile X-ray system is not designed to be water-resistant. If cleaned improperly, it could become damaged. This damage might affect the system's functionality.

Who’s affected

Medical facilities using the SEDECAL mobile X-ray system model SM-40HF-B-D-C are likely affected. Staff handling the equipment during cleaning are at risk of damage.

How to tell if you have this one

Check for the model number SM-40HF-B-D-C on the device. Affected units have serial number G37528. The product was sold with specific UDI/DI 08436046001510.

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

What model numbers are affected?

Model SM-40HF-B-D-C (40KW 55C) with serial number G37528.

How can I tell if my unit is affected?

Check for model number SM-40HF-B-D-C and serial number G37528 on the device.

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-0259-2026 — SEDECAL SEDECAL

Hello,

I own a SEDECAL that is covered by recall Z-0259-2026 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-0259-2026 (June 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0259-2026 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 55C, Mobile X-ray system

Lower-risk recall