What is the RADPRO MOBILE recall about?

Sedecal SA is recalling 24 RADPRO MOBILE mobile X-ray systems due to a safety notice about cleaning. The equipment is not water-resistant, and cleaning must follow the manual to avoid potential harm.

How many units are affected and where were they distributed?

Twenty-four units were distributed in the United States, including California, Illinois and New Jersey.

Are there any reported injuries from this recall?

No injuries or incidents have been reported to date.

What should hospitals do right now?

Stop using the device and follow the recall instructions provided by Sedecal SA. Contact the manufacturer or a healthcare supervisor for guidance.

How do I identify if my device is affected?

Refer to the model numbers and serial numbers listed in the recall materials. The UDI/DI and serial numbers include items like 08436046002166 and G30567 among others.

Where can I find contact information for Sedecal SA?

The recall data provides a generic instruction to contact Sedecal SA through official channels. Specific phone numbers or hours are not included in the provided data.

What is the remedy for affected units?

The remedy is to stop using the device and follow the manufacturer’s recall instructions. There is no refund information in the provided data.

Will replacements or refunds be offered?

No replacement or refund details are provided in the data. Follow Sedecal SA instructions for next steps.

Is this recall part of a broader pattern in medical devices?

There is no information indicating it is part of a broader pattern in the provided data.

How long will it take to resolve the recall?

The recall timeline is not specified in the data. Hospitals should await instructions from Sedecal SA.

What should I document for records?

Document the device model/serial numbers, recall notice, communications with Sedecal SA, and any steps taken to stop use.

What other steps can I take to ensure patient safety?

Follow cleaning instructions exactly as per the manual, and verify any formal guidance from the manufacturer or health authorities before restarting use.

Who should be notified if there is a patient in potential danger?

Notify hospital risk management and the treating clinician. If needed, contact local health authorities for guidance.

HIGHFDA DEVICEJune 10, 2025

Sedecal RADPRO MOBILE Mobile X-ray System Recall Affects 24 Units in 2025

Sedecal SA recalls 24 RADPRO MOBILE mobile X-ray systems distributed in California, Illinois and New Jersey. A vendor notice warns the equipment is not water-resistant and must be cleaned strictly per the manual. Improper cleaning could have harmful consequences. Hospitals and clinics should stop using the device immediately and follow the manufacturer’s recall instructions.

Official notice

Sedecal SA Health & Personal Care Medical DevicesUDI/DI 08436046002166G30567G31256

Source-backed recall notice

No product image was available from the source feed.

Official source: FDA DEVICE
Recall date: June 10, 2025
Status: ACTIVE
Severity: 6/10

Quick Facts at a Glance

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

1Stop using the product until you confirm whether it is included in the recall.
2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand: Sedecal SA
Product type: Mobile X-ray System
Model numbers: UDI/DI 08436046002166, G30567, G31256, G32581, G30250, G28320, G30902, G29864 +12 more
Sold at: Multiple Retailers
Where affected: CA, IL, NJ

Recall Timeline

Key dates and source checks for this recall record.

Recall announced
June 10, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.

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

About This Product

The RADPRO MOBILE is a portable X-ray system used by healthcare professionals to perform radiographic imaging at patient bedsides or remote locations.

Why This Is Dangerous

The device is not water-resistant and must be cleaned only according to the manual. Improper cleaning could cause electrical or operational hazards.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

Hospitals and clinics may face workflow disruptions. Stopping use could impact imaging capabilities until corrective steps are provided.

Practical Guidance

How to identify if yours is affected

Check the device against the listed model/UDI and serial numbers.
Review your inventory for any units matching the recall list.
Verify the device is not in use until further notice.

Where to find product info

Recall notice and model/serial number details are in the FDA enforcement report linked in the source data.

What timeline to expect

No timeline is provided in the data. Hospitals should await instructions from Sedecal SA.

If the manufacturer is unresponsive

Escalate to hospital risk management.
Request written guidance from Sedecal SA via official channels.

How to prevent similar issues

Ensure staff are trained to follow manual cleaning procedures exactly.
Document all device cleaning steps and any deviations.
Maintain a log of all portable X-ray systems and their recall status.

Documentation advice

Keep the recall notice, device identifiers, and all communications with Sedecal SA as part of a compliance record.

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Product Details

Brand: Sedecal SA Product: RADPRO MOBILE Mobile X-ray system Quantity: 24 units Distribution: United States (CA, IL, NJ) Model numbers/UDIs: UDI/DI 08436046002166; Serial Numbers: G30567, G31256, G32581, G30250, G28320, G30902, G29864, G35389, G30960, G33238, G31252, G33708, G30771, G33634, 31412, 31480, G33004, G33112, G33585 Sold since: Unknown Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

Not water-resistant design warning
Cleaning must follow manual
Distribution in CA, IL, NJ
Active recall as of 2025-06-10

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

Jun 10, 2025

Sedecal SA

Sedecal sent