What is being recalled and why?

Sedecal SA recalls 181 SM-40HF-B-D-C mobile X-ray systems because the units are not water-resistant and must be cleaned per the manual. Improper cleaning could lead to unsafe conditions.

What should facilities do right away?

Stop using the device and follow the manufacturer recall instructions. Contact Sedecal SA or a healthcare provider for further guidance.

Where can I find more details?

The recall notice is posted on the FDA enforcement page linked in the recall record.

Will I get a refund or replacement?

The notice mentions a recall remedy but does not specify refunds. Follow the provided recall instructions for next steps.

How will the recall be communicated to facilities?

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

What if my facility cannot reach Sedecal SA?

Document all attempts to contact, follow interim guidance from your healthcare administrator, and use the official FDA recall page for updates.

Is there a risk to patients during use?

The recall centers on cleaning procedures and water exposure risk. Facilities should halt use until instructions are followed.

What identifiers should I check on my device?

Check the model SM-40HF-B-D-C, the UDI/DI 08436046001510, and the listed serial numbers on the unit label.

How long will remediation take?

The recall notice does not specify a remediation timeline; facilities should await instructions from Sedecal SA or the FDA update.

HIGHFDA DEVICEJune 10, 2025

Sedecal SA Recalls 181 SM-40HF-B-D-C Mobile X-ray Systems for Cleaning Not Water-Resistant Risk (202

Q: Which models are affected?

Model SM-40HF-B-D-C with UDI/DI 08436046001510 and listed serial numbers such as D11-40KW-F, G36689, G37293, G38198, G38657, G38385, G37687, G36643, G41114, G36137, G36761, G36272, G37188, G37359, G37456, G38178, G62012, G62059, G62892.

Sedecal SA recalls 181 SM-40HF-B-D-C mobile X-ray systems in 2025 after concerns about cleaning and water resistance. The device is not water-resistant and must be cleaned strictly according to the manual. Manufacturers warn of potential consequences if cleaning is not followed. Hospitals and clinics should stop using the device and follow recall instructions immediately.

Official notice

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

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: 8/10

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
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 mobile X-ray system used in hospitals and clinics for portable imaging. It operates at 40KW and 70C, designed for on-site radiography.

Why This Is Dangerous

The device is not water-resistant. Cleaning must follow the manual to avoid adverse conditions. Improper cleaning could compromise safety or equipment integrity.

Industry Context

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

Real-World Impact

Facilities must stop using the unit until instructions are provided. Image acquisition and patient flow could be disrupted while awaiting remediation.

Practical Guidance

How to identify if yours is affected

Confirm unit model SM-40HF-B-D-C and UDI/DI 08436046001510.
Verify serial numbers against the recall list.
Review the device label for identifiers.

Where to find product info

Device labels show model, UDI/DI, and serial numbers. Official recall details are on the FDA enforcement page linked in the notice.

What timeline to expect

Remedy timeline not specified in the notice. Expect manufacturer guidance and FDA updates.

If the manufacturer is unresponsive

Document attempts to contact Sedecal SA
Engage your hospital procurement or biomedical engineering department
Use FDA recall page for updates and report concerns to regulators

How to prevent similar issues

Ensure strict adherence to cleaning per the manual
Avoid any cleaning methods that involve water exposure
Coordinate with service professionals for cleaning procedures

Documentation advice

Keep copy of the recall notice, emails, and communication with Sedecal SA. Log serial numbers, UDI, and device condition before and after remediation.

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Product Details

Model: SM-40HF-B-D-C; 40KW 70C mobile X-ray system. Quantity: 181 units. Distribution: United States in CA, IL, and NJ. UDI/DI: 08436046001510. Serial Numbers include D11-40KW-F, G36689, G37293, G38198, G38657, G38385, G37687, G36643, G41114, G36137, G36761, G36272, G37188, G37359, G37456, G38178, G62012, G62059, G62892. Sold/price: not disclosed.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

Model SM-40HF-B-D-C; 40KW 70C
Not water-resistant; cleaning per manual required
Serial numbers listed in recall include D11-40KW-F and multiple G- numbers
Distribution in CA, IL, NJ; US market only

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Jun 10, 2025

Sedecal

Sedecal sent