SEDECAL Mobile X-ray System Not Water-Resistant: Clean Properly to Avoid Damage

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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's Mobile X-ray system (SED URS LP) is recalled because it is not water-resistant. Improper cleaning could cause damage to the equipment. This recall does not involve safety risks to users.

Why it’s dangerous

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

Who’s affected

Users of SEDECAL's Mobile X-ray system (SED URS LP) who have the equipment. Medical facilities using this model are most at risk of equipment damage.

How to tell if you have this one

Check for the model name 'SED URS LP' and serial numbers starting with 40116. The equipment was sold without a unique identifier.

Brand
SEDECAL
Category
Medical device

Based on the official FDA remedy

What to do — step by step

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

✎ GovInfoNow

Questions people ask

Is this recall dangerous to users?

No, the recall is for equipment damage only, not safety risks.

What should I do if I have this equipment?

Follow the manual's cleaning instructions to prevent damage; no action is needed beyond proper cleaning.

Is there a fix or replacement available?

The official notice does not specify a remedy or replacement.

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-0282-2026 — SEDECAL SEDECAL

Hello,

I own a SEDECAL that is covered by recall Z-0282-2026 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-0282-2026 (June 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0282-2026 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 SED URS LP, Mobile X-ray system

Lower-risk recall