What is recalled and why?

Sedecal SA recalls 9 units of the SM-40HF-Batt 40KW analog Mobile X-ray System because the devices are not water-resistant and must be cleaned per the manual. Improper cleaning could cause damage or compromise function.

Which units are affected?

Units with model SM-40HF-Batt and the listed UDI/DI 08436046001114 and serial numbers G24948, G25512, C25673, 25901, G25771, G26990, G25506, G22189, G30240 are affected.

Where were the units distributed?

Distributed in the United States in California, Illinois and New Jersey.

What should I do if I own one?

Stop using the device immediately and follow the recall instructions. Contact Sedecal SA or your healthcare provider for guidance.

Is there an immediate harm from this recall?

The recall focuses on cleaning and water-resistance. There is no reported injury in the notice, but improper cleaning could pose a risk.

Will there be a refund or replacement?

The recall notice does not specify refunds or replacements. Contact Sedecal SA for instructions.

Where can I find more information?

Refer to the FDA enforcement page linked in the notice for official recall details.

What should facility managers do?

Immediately halt use and implement the manufacturer’s cleaning instructions to avoid potential issues.

How will I verify my device’s identity?

Check the device label for SM-40HF-Batt, the UDI/DI 08436046001114, and the serial numbers listed above.

What if the device is no longer in service?

Keep the device out of service and contact Sedecal SA for disposition guidance.

HIGHJune 10, 2025

Sedecal SA Recalls 9 SM-40HF-Batt Mobile X-ray Systems (2025)

Sedecal SA is recalling 9 units of the SM-40HF-Batt 40KW analog Mobile X-ray System distributed in California, Illinois and New Jersey. The company sent an email to consignees warning the equipment is not water-resistant and must be cleaned strictly per the manual. Improper cleaning could cause system damage. Hospitals and clinics should stop using the devices immediately and contact Sedecal SA or

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 SA produces radiology equipment including mobile X-ray systems used in hospitals and clinics to image patients at bedside or in transport.

Why This Is Dangerous

The device is not water-resistant and requires cleaning per the manual. Improper cleaning could damage the unit or affect safety during operation.

Industry Context

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

Real-World Impact

Hospitals and clinics may need to quarantine these units and review cleaning protocols. The impact is operational and safety-oriented rather than a consumer product hazard.

Practical Guidance

How to identify if yours is affected

Confirm the device is a SM-40HF-Batt 40KW analog Mobile X-ray System
Check UDI/DI 08436046001114
Review serial numbers: G24948, G25512, C25673, 25901, G25771, G26990, G25506, G22189, G30240
Note distribution: CA, IL, NJ in the US
Review date: recall dated 2025-06-10

Where to find product info

Device labels show model, UDI/DI, and serial numbers; recall notice available on FDA enforcement page

What timeline to expect

Refunds or replacements are not specified; manufacturers typically resolve within weeks to months after confirmation

If the manufacturer is unresponsive

Document all communications with Sedecal SA
Escalate to hospital procurement and regulatory contacts if needed
Consult FDA or patient safety authorities if no response

How to prevent similar issues

Ensure cleaning steps match the manual specifications
Avoid using equipment after cleaning until approved
Keep a log of cleaning procedures and dates for each device
Verify UDI and serial numbers against recall list before use
Consider alternative interim imaging options until replacement guidance is issued

Documentation advice

Record model, UDI, serial numbers, distribution locations, recall notices, and all correspondence with Sedecal SA.

Product Details

Model numbers: SM-40HF-Batt. UDI/DI: 08436046001114. Serial numbers: G24948, G25512, C25673, 25901, G25771, G26990, G25506, G22189, G30240. Sold in the US: CA, IL, NJ. Recall date: 2025-06-10. Status: ACTIVE. Quantity: 9 units. Manufacturer: Sedecal SA.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

9 units recalled
Distribution in CA, IL, NJ (US)
Model SM-40HF-Batt; UDI/DI 08436046001114
Serial numbers: G24948, G25512, C25673, 25901, G25771, G26990, G25506, G22189, G30240
Not water-resistant; cleaning per manual
Recall date 2025-06-10; Status ACTIVE

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

6/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeMobile X-ray System

Product Details

Brand

Sedecal SA

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