What models are affected by the Sedecal recall Z-0252-2026?

The recall covers Model 40KWFXPLUS-710CW.007 with UDI 08436046002166 and listed Serial Numbers G79192, G79195, G79212, G78205, G80256, G79692, G80053.

Should I stop using my Sedecal mobile X-ray system right away?

Yes. The recall advises stopping use immediately and following the manufacturer’s instructions.

How can I verify if my device is affected?

Check the model number 40KWFXPLUS-710CW.007, the UDI 08436046002166, and the listed serial numbers. Compare with your device documentation.

What should I do if I own an affected unit?

Discontinue use and contact Sedecal SA or your healthcare provider for remediation instructions. Refer to the FDA recall page for updates.

Will Sedecal provide a replacement or repair?

The recall notice directs users to follow manufacturer instructions. It does not specify a refund, replacement, or repair program in the text provided.

Where can I find more information about this recall?

Visit the FDA enforcement page for Z-0252-2026 and Sedecal’s official recall communications for details.

Is there a risk if the device is cleaned improperly?

Improper cleaning can have consequences outlined by the manual. The device is not water-resistant, so cleaning must follow the manual to avoid operational or safety issues.

What is the safe interim use guidance for facilities with this equipment?

Continue to monitor the recall notice and comply with all stated requirements. Engage risk management and notify staff about stopping use until further instructions are issued.

Where can I report adverse events related to this recall?

Adverse events should be reported to the FDA and Sedecal according to local regulatory requirements. Refer to the FDA recall page for instructions.

What date did this recall start?

The recall began on 2025-06-10 and the report date is 2025-10-29.

HIGHJune 10, 2025

Sedecal Recalled 7 Mobile X-ray Systems Over Cleaning Not Water-Resistant Issue (2025)

Sedecal recalled 7 mobile X-ray systems distributed to California, Illinois and New Jersey after warning that the equipment is not water-resistant and must be cleaned strictly per the manual. The notice highlights potential consequences of improper cleaning. Hospitals and clinicians should stop using the device and follow the manufacturer’s recall 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

Sedecal's 40KWFXPLUS-710CW.007 is a mobile X-ray system used in clinical settings to perform radiographic imaging at patient bedsides or remote locations. Such devices support diagnostic imaging in hospitals and clinics. They are typically owned and operated by healthcare facilities and managed by hospital staff.

Why This Is Dangerous

The device is not water-resistant and must be cleaned strictly according to the manual. Improper cleaning could compromise function or safety, according to the recall notice.

Industry Context

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

Real-World Impact

Facilities with the affected units must halt use and coordinate with Sedecal for remediation. The immediate safety impact is operational disruption and potential patient-care delays if replacements or repairs are required.

Practical Guidance

How to identify if yours is affected

Verify device model number is 40KWFXPLUS-710CW.007
Check UDI/DI 08436046002166
Review serial numbers for G79192, G79195, G79212, G78205, G80256, G79692, G80053

Where to find product info

Recall notice and updates are available on the FDA enforcement page linked in the recall and Sedecal's communications.

What timeline to expect

Remedy timeline is not specified in the notice.

If the manufacturer is unresponsive

Escalate with hospital risk management
Consult FDA guidelines for medical device recalls
Document all communications with Sedecal SA

How to prevent similar issues

Always follow the device cleaning instructions in the manual
Do not submerge or expose the device to liquids beyond what the manual allows
Store and maintain cleaning records for future audits

Documentation advice

Keep a copy of the recall notice, all emails, serial numbers, and model verification. Photograph any labels and date codes for evidence.

Product Details

Model: 40KWFXPLUS-710CW.007; Brand: Sedecal SA; Product: Mobile X-ray system; UDI/DI: 08436046002166; Serial Numbers: G79192, G79195, G79212, G78205, G80256, G79692, G80053; Units recalled: 7; Regions: US (CA, IL, NJ); Recall date: 2025-06-10; Report date: 2025-10-29; Status: ACTIVE; Reason: Not water-resistant and must be cleaned per manual; Remedy: Stop using the device; follow recall instructions; contact Sedecal SA or healthcare provider; Reference: FDA recall page Z-0252-2026.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

7 units recalled in US distribution (CA, IL, NJ).
Model 40KWFXPLUS-710CW.007; UDI/DI 08436046002166; Serial numbers G79192, G79195, G79212, G78205, GU
G80256, G79692, G80053
Recall initiated 2025-06-10; report date 2025-10-29
Not water-resistant; cleaning must follow manual

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

7/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeMobile X-ray system

Product Details

Jun 10, 2025

Sedecal SA

Sedecal sent