SEDECAL Mobile X-ray System SM-40HF-B-D-C: 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 SM-4:0HF-B-D-C because it is not water-resistant. Using it without proper 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. This might affect its functionality and safety.

Who’s affected

Users of the SEDECAL mobile x-ray system SM-40HF-B-D-C with serial numbers G36566 or UDI/DI 08436046001510 are affected. Medical facilities using this model are most at risk.

How to tell if you have this one

Check for model number SM-40HF-B-D-C and serial number G36566 or UDI/DI 08436046001510. The system is sold as a 40KW CANON READY.005 mobile x-ray system.

Brand
SEDECAL
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Number
Look for model number SM-40HF-B-D-C on the device.
Verify Serial Number
Check the serial number G36566 or UDI/DI 08436046001510.

✎ GovInfoNow

Questions people ask

Is this x-ray system safe to use?

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

What should I do if I have this x-ray system?

The recall does not specify a remedy, so no action is required beyond checking the model and serial numbers.

How can I tell if my x-ray system is affected?

Affected units have model number SM-40HF-B-D-C and serial number G36566 or UDI/DI 08436046001510.

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-0276-2026 — SEDECAL SEDECAL

Hello,

I own a SEDECAL that is covered by recall Z-0276-2026 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-0276-2026 (June 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0276-2026 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 CANON READY.005, Mobile X-ray system

Lower-risk recall