What is being recalled?

The Sedecal SM-40HF-B-D-C 40KW mobile X-ray system is being recalled. The recall concerns cleaning requirements and the device not being water-resistant.

How many units are affected?

Four units are affected by this recall in the United States.

Where were the units distributed?

Distribution covers California, Illinois and New Jersey.

What should I do if I own this device?

Stop using the device immediately. Follow the manufacturer’s recall instructions and contact Sedecal SA or your healthcare provider for guidance.

Are there any reported injuries?

No injuries or incidents have been reported to date.

How can I verify if my unit is affected?

Check model number SM-40HF-B-D-C; verify the UDI 08436046001510 or serial numbers G32487, 31414, G35462, G32657.

Who can I contact for more information?

Refer to the FDA recall page linked in the article and contact Sedecal SA for instructions.

Will there be a refund or replacement?

The recall notice directs stopping use and following manufacturer instructions. For refunds or replacements, contact the manufacturer.

How long will the recall process take?

No timetable is provided. Follow the manufacturer’s instructions and FDA updates.

What should hospitals do during the recall?

Cease use of affected units and implement the manufacturer’s guidance immediately.

Where can I find the official recall notice?

The FDA enforcement page provides official recall details.

HIGHJune 10, 2025

Sedecal SA Recalls 4 SM-40HF-B-D-C Mobile X-ray Systems in 2025

Q: Is there a safety risk?

The safety note is that the unit is not water-resistant and must be cleaned per the manual. Improper cleaning could have safety implications, though no injuries are reported.

Sedecal SA recalled 4 SM-40HF-B-D-C 40KW mobile X-ray systems sold in California, Illinois and New Jersey. A notice warns the equipment is not water-resistant and must be cleaned exactly as described in the manual to avoid possible consequences of improper cleaning. Healthcare providers should stop using the device immediately and contact Sedecal SA or their provider for instructions.

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

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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

About This Product

Mobile X-ray systems are used in hospitals to perform radiographic exams at a patient’s bedside. They are critical for quick imaging in acute settings.

Why This Is Dangerous

The device is not water-resistant and must be cleaned per the manual. Improper cleaning could cause safety or equipment issues.

Industry Context

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

Real-World Impact

Affects 4 units in the US. Requires immediate cessation of use and guidance from the manufacturer. No injuries reported yet.

Practical Guidance

How to identify if yours is affected

1) Confirm model number SM-40HF-B-D-C; 2) Check UDI 08436046001510; 3) Check serial numbers G32487, 31414, G35462, G32657; 4) Confirm distribution states CA, IL, NJ.
whereToFindInfo:
timelineExpectation:
ifUnresponsive: [

Where to find product info

FDA recall page and Sedecal SA notices; Manufacturer contact information will be provided by Sedecal SA.

What timeline to expect

4-8 weeks typical for recall communications, but this recall provides no specific timeframe.

If the manufacturer is unresponsive

Document all attempts to contact the manufacturer
Escalate to hospital risk management
Reach out to FDA recall program if needed

How to prevent similar issues

Ensure cleaning procedures align with the manual during procurement
Verify water-resistance ratings before purchase of imaging equipment
Train staff on cleaning protocols for non-water-resistant devices

Documentation advice

Keep a copy of the recall notice, document serial numbers, take photos of labels, save all correspondence with Sedecal SA

Product Details

Model numbers: SM-40HF-B-D-C; 40KW 50C Where sold: United States, California, Illinois, New Jersey When sold: Unknown Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

4 units recalled
Distribution in CA, IL, NJ
Not water-resistant; cleaning per manual required
No injuries or incidents reported
Stop using immediately; contact Sedecal SA for instructions

View Original Recall on FDA - Medical Devices

Browse More Recalls

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeMobile X-ray System

Product Details

Brand

Sedecal SA

Related Recalls

Health & Personal Care

HIGH

Sedecal SA Recalled 1 Mobile X-ray System 40KWFXPLUS.889 in 2025 for Cleaning Not Water-Resistant

Sedecal SA recalled 1 unit of the Mobile X-ray System 40KWFXPLUS.889 distributed in California, Illinois and New Jersey. The recall concerns cleaning practices and the device not being water-resistant. Hospitals and clinics should stop using the device immediately and follow recall instructions. Contact Sedecal SA for instructions via the recall notice distributed by email.

Jun 10, 2025

Sedecal SA

Sedecal sent

Health & Personal Care

HIGH

Sedecal SA Recalled 5 SM-40HF-B-D-C Mobile X-ray Systems for Cleaning Warning (2025)

Sedecal SA recalled 5 SM-40HF-B-D-C 40KW 55G Mobile X-ray systems distributed in the US (CA, IL, NJ) after warning that the equipment is not water-resistant and must be cleaned strictly per the manual. The notice outlines the possible consequences of improper cleaning. Healthcare facilities should stop using the devices immediately and contact Sedecal SA for instructions.

Jun 10, 2025

Sedecal SA

Sedecal sent

Health & Personal Care

HIGH

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

Jun 10, 2025

Sedecal SA

Sedecal sent

Health & Personal Care

HIGH

Sedecal SA Recalls 17 SM_40HF_B_D_VIR3 Mobile X-ray Systems Over Water-Resistance Cleaning Risk (202

Sedecal SA recalled 17 SM_40HF_B_D_VIR3 Mobile X-ray systems distributed in California, Illinois and New Jersey after emailing consignees that the equipment is not water-resistant and must be cleaned exactly as the manual directs. The notices warn about consequences of improper cleaning. Hospitals and clinics should stop using the device and follow the recall instructions from Sedecal SA or their

Jun 10, 2025

Sedecal SA

Sedecal sent

Health & Personal Care

HIGH

Sedecal SA Recalls Shimadzu RF.004 Mobile X-ray System in 2025

Sedecal SA is recalling the Shimadzu RF.004 Mobile X-ray System after warnings that the device is not water-resistant and must be cleaned strictly according to the manual. Hospitals in California, Illinois, and New Jersey are affected. Stop using the device and follow recall instructions.

Jun 10, 2025

Sedecal SA

Sedecal sent

Health & Personal Care

HIGH

Sedecal SA Recalls 1 Unit 40KW-FX.899 Mobile X-ray System Over Cleaning Hazard (2025)

Sedecal SA recalled 1 unit of the 40KW-FX.899 Mobile X-ray System distributed to CA, IL and NJ. The device is not water-resistant and must be cleaned strictly per the manual. Improper cleaning could cause adverse effects. Stop using the device and contact Sedecal SA or a healthcare provider for instructions.

Jun 10, 2025

Sedecal SA

Sedecal sent

Health & Personal Care

HIGH

Sedecal SA Recalls 22 SM-32HF-Batt Mobile X-ray Systems for Cleaning Risk (2025)

Sedecal SA recalled 22 SM-32HF-Batt 32KW analog mobile X-ray systems distributed to California, Illinois and New Jersey. The units are not water-resistant and must be cleaned strictly per the manual, with explicit consequences for improper cleaning. Healthcare facilities should stop using the devices immediately and follow the manufacturer's recall instructions sent by email.

Jun 10, 2025

Sedecal SA

Sedecal sent

Health & Personal Care

LOW

Sedecal SA Recalls 12 40KWFXPLUS-710CW Mobile X-ray Systems for Cleaning Risk (2025 Recall)

Sedecal SA recalled 12 units of the 40KWFXPLUS-710CW Mobile X-ray system distributed to CA, IL and NJ. The recall cites that the equipment is not water-resistant and must be cleaned strictly per the manual to avoid consequences of improper cleaning. Hospitals and clinics should stop using the device immediately and follow the manufacturer’s recall instructions.

Jun 10, 2025

Sedecal SA

Sedecal sent