Is there any reported injury from this recall?

No injuries or incidents have been reported to date.

Which units are affected?

One unit, model 40KW-FX.899 with UDI/DI 08436046002166 and serial G72770, distributed to CA, IL and NJ.

What should users do now?

Stop using the device. Follow the recall instructions from the manufacturer. Contact Sedecal SA or a healthcare provider for instructions.

Where can I find the recall notice?

The recall notice is available on the FDA enforcement page linked to Z-0245-2026.

Will I get a replacement or refund?

Remedies will be provided per Sedecal SA instructions. Check the FDA notice for guidance on refunds or replacements.

How do I identify if my unit is affected?

Check the model 40KW-FX.899 and confirm UDI/DI 08436046002166 with serial G72770.

What about cleaning procedures?

Cleaning must follow the manual exactly. Do not use water on the device beyond what the manual allows.

Who should I contact for instructions?

Contact Sedecal SA or your healthcare provider for device-specific instructions.

How long will it take to resolve this recall?

The recall process timeline is not specified in the notice.

Is this recall part of a broader pattern?

The notice indicates a specific risk tied to cleaning and water exposure for this unit.

What should facilities do to protect patients?

Immediately halt use of the device until instructions are received from Sedecal SA or the hospital risk manager.

HIGHJune 10, 2025

Sedecal SA Recalls 1 Unit 40KW-FX.899 Mobile X-ray System Over Cleaning Hazard (2025)

Q: What is being recalled and why?

Sedecal SA is recalling 1 unit of the 40KW-FX.899 Mobile X-ray System because it is not water-resistant and must be cleaned strictly per the manual to avoid potential safety concerns in a healthcare setting.

Sedecal SA recalled 1 unit of the 40KW-FX.899 Mobile X-ray System distributed to CA, IL and NJ. The device is not water-resistant and must be cleaned strictly per the manual. Improper cleaning could cause adverse effects. Stop using the device and contact Sedecal SA or a healthcare provider for instructions.

Quick Facts at a Glance

Recall Date: June 10, 2025
Hazard Level: HIGH
Brand: Sedecal SA
Category: Health & Personal Care
Sold At: Unknown
Geographic Scope: 3 states
At-Risk Groups: GENERAL

Hazard Information

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SEDECAL SA or your healthcare provider for instructions. Notification method: E-Mail

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About This Product

The 40KW-FX.899 is a mobile X-ray system used in clinical settings for point-of-care imaging. It requires periodic cleaning according to the user manual.

Why This Is Dangerous

The device is not water-resistant. Cleaning must follow the manual to avoid damage or safety hazards. Improper cleaning could compromise device function or patient safety.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Hospitals and clinics with the device must halt use until instructed by the manufacturer. The issue could disrupt imaging workflows and require reallocation of equipment.

Practical Guidance

How to identify if yours is affected

Verify unit is the 40KW-FX.899 model.
Check UDI/DI 08436046002166 and serial G72770.
Confirm distribution states CA, IL, NJ.

Where to find product info

Recall notice and FDA enforcement page linked above. Manufacturer communications and device manual.

What timeline to expect

No specific resolution timeframe provided. Recalls typically depend on manufacturer and facility readiness.

If the manufacturer is unresponsive

Document all communications with Sedecal SA.
Escalate to hospital risk management or patient safety office if responses are delayed.
File a complaint with the FDA if the manufacturer does not respond within a reasonable period.

How to prevent similar issues

Verify cleaning protocols before procurement.
Ensure staff follows the manual for cleaning and water exposure limitations.
Request written recall instructions and keep them on file.
Consider safer alternatives or additional protective measures for future purchases.

Documentation advice

Retain all recall notices, email communications, and any responses from Sedecal SA. Record unit identifiers and dates of communications.

Product Details

Model numbers: UDI/DI 08436046002166; Serial Numbers: G72770. Sold at: Unknown. When sold: Unknown. Price: Unknown. Recall date: 2025-06-10. Quantity: 1 unit. Country of origin: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

1 unit recalled
Model UDI/DI 08436046002166; Serial G72770
Hazard: not water-resistant; cleaning per manual
Distribution: US CA, IL, NJ
Recall date: 2025-06-10
Status: Active (FDA Z-0245-2026) Manufacturer: Sedecal SA

View Original Recall on FDA - Medical Devices

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH

Severity Score

7/ 10

Affected Groups

GENERAL

Injury Types

ELECTRICALOTHER

Product Classification

CategoryHealth & Personal Care › Medical Imaging Equipment

Product TypeMobile X-ray system

Product Details

Brand

Sedecal SA

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