What is being recalled?

The Sedecal SM-40HF-B-D-C 40KW Mobile X-ray System. Six units are affected. The device is not water-resistant and requires cleaning per the manual.

Are there injuries linked to this recall?

No injuries or incidents have been reported to date.

Why was this recall issued?

Because improper cleaning due to not following the manual could create safety risks or equipment damage.

How can I tell if my device is affected?

Check the model number SM-40HF-B-D-C, the UDI/DI 08436046001510, and serial numbers G39822, G62662, G62564, G61702, G60067, G38060.

What should I do right now if I own this device?

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

How was the recall communicated?

Notification was issued by email to consignees, per the recall notice.

When did the recall begin?

The recall recall date is 2025-06-10 and the enforcement status is active.

Where was the device distributed?

Distribution in the United States includes California, Illinois and New Jersey.

Will I receive a refund or replacement?

Refund details are not specified in the recall notice. Follow manufacturer instructions for remedy options.

Where can I get more information?

Refer to the FDA enforcement page linked in the recall notice, Z-0274-2026.

What about cleaning the device?

Follow the cleaning instructions in the manual. Do not improvise water-based cleaning.

What should I do if I can't reach Sedecal?

Document attempts to contact the company and consult your healthcare provider for interim guidance.

Is this recall part of a larger industry trend?

The recall notice describes a specific issue for this model. The record does not indicate a broader pattern at this time.

What is the impact on patient care?

Hospitals and clinics with the affected units should stop using them until further instructions are provided to reduce risk to patients.

HIGHFDA DEVICEJune 10, 2025

Sedecal SM-40HF-B-D-C 40KW Mobile X-ray System Recalled for Cleaning Not Water-Resistant Hazard (202

Sedecal SA recalls 6 units of the SM-40HF-B-D-C 40KW 80C Mobile X-ray system after warning consignees that the device is not water-resistant and must be cleaned strictly according to the manual. Improper cleaning could lead to safety risks. Hospitals and clinics in California, Illinois and New Jersey should stop using the device and follow the manufacturer's recall instructions.

Official notice

Sedecal Health & Personal Care Medical DevicesSM-40HF-B-D-CUDI/DI 08436046001510G39822

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: 7/10

Quick Facts at a Glance

Recall Date: June 10, 2025
Hazard Level: HIGH
Brand: Sedecal
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
Product type: Mobile X-ray system
Model numbers: SM-40HF-B-D-C, UDI/DI 08436046001510, G39822, G62662, G62564, G61702, G60067, G38060
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 SM-40HF-B-D-C is a 40KW 80C mobile X-ray system used in clinical settings for point-of-care imaging.

Why This Is Dangerous

Sedecal notes the device is not water-resistant. Cleaning must follow the manual to avoid damage or safety risks. Improper cleaning could compromise function or safety.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Hospitals and clinics with the device should stop using it immediately to prevent potential safety risks. The recall affects 6 units in the US distributed to CA, IL, NJ.

Practical Guidance

How to identify if yours is affected

Locate the model number on the device label
Check the UDI/DI 08436046001510
Compare with the list in Product Details
If any match, do not use the device until instructed

Where to find product info

Model plate on the device, UDI/DI label and serial number tags

What timeline to expect

Recall processing and potential replacement or guidance may take weeks; typical 4-8 weeks

If the manufacturer is unresponsive

Document attempts to contact Sedecal SA
Escalate to your healthcare provider
File a complaint with FDA recall enforcement if needed

How to prevent similar issues

Verify water-resistance and cleaning instructions before purchase
Follow manual cleaning procedures
Monitor for recall notices and email alerts

Documentation advice

Save the recall notice, emails, and any responses from Sedecal SA; photograph serial numbers, model numbers

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Product Details

Model numbers: SM-40HF-B-D-C; 40KW 80C; UDI/DI 08436046001510; Serial Numbers: G39822, G62662, G62564, G61702, G60067, G38060. Sold to consignees in the US, including California, Illinois, and New Jersey. Sold date: Unknown. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

Distribution: US states CA, IL, NJ
Model numbers: SM-40HF-B-D-C; UDI/DI 08436046001510; Serial Numbers G39822, G62662, G62564, G61702,G
Hazard: Not water-resistant; improper cleaning per 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

Jun 10, 2025

Sedecal

Sedecal sent