What is being recalled?

Sedecal SA recalls 6 mobile X-ray systems, model SM-40HF-B-D-C; 40KW.005, distributed in the United States. The devices are not water-resistant and require cleaning only per the manual.

Which units are affected?

Six units with model SM-40HF-B-D-C; 40KW.005 and associated serials UDI 08436046001510, G64274, G40012, G64597, G70742, G72764, G61804 are implicated and distributed to CA, IL, and NJ.

Improper cleaning could lead to device problems because the equipment is not water-resistant and must be cleaned strictly according to the manual.

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 further guidance.

How do I identify if my unit is affected?

Check model SM-40HF-B-D-C; 40KW.005 and cross-reference serials UDI 08436046001510 or G64274, G40012, G64597, G70742, G72764, G61804.

Is there an injury risk?

No injuries are reported in the recall as of the enforcement notice. The hazard relates to cleaning and operation integrity.

How will I get a remedy?

Remedy instructions were provided via email from Sedecal SA. Follow those instructions or contact Sedecal for guidance.

Where can I get more information?

See the FDA enforcement page for Recall Z-0279-2026 and your healthcare facility’s Sedecal contact channels.

Will I receive a replacement or refund?

The recall notice does not specify refunds. Follow Sedecal’s instructions for remediation or replacement options.

What if the company is slow to respond?

Document all communications and contact your hospital risk management or regulatory authority for escalation.

HIGHFDA DEVICEJune 10, 2025

Sedecal Mobile X-ray Systems Recall 6 Units for Cleaning Not Water-Resistant Risk (2025)

Sedecal SA recalled 6 mobile X-ray systems in the United States on June 10, 2025 after warning that the devices are not water-resistant and must be cleaned strictly per the manual. The recall notes possible consequences of improper cleaning. Healthcare facilities should stop using the devices immediately and follow Sedecal's recall instructions.

Official notice

Sedecal Health & Personal Care Medical DevicesSM-40HF-B-D-C; 40KW.005UDI/DI 08436046001510G64274

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: 5/10

Quick Facts at a Glance

Recall Date: June 10, 2025
Hazard Level: HIGH
Brand: Sedecal
Category: Health & Personal Care
Sold At: Unknown
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; 40KW.005, UDI/DI 08436046001510, G64274, G40012, G64597, G70742, G72764, G61804
Sold at: Unknown
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

Sedecal mobile X-ray systems are used in medical facilities to perform radiographic imaging at the point of care. They are designed for mobility within hospitals and clinics.

Why This Is Dangerous

The device is not water-resistant and must be cleaned exactly as described in the manual. Improper cleaning could compromise device function or safety.

Industry Context

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

Real-World Impact

Facilities may experience downtime during remediation, potential equipment damage if cleaning rules are ignored, and escalation overhead as providers follow recall directions.

Practical Guidance

How to identify if yours is affected

Verify model SM-40HF-B-D-C; 40KW.005
Confirm distribution to CA, IL, NJ; check internal device records

Where to find product info

Model label on device, UDI label, and official recall page linked above

What timeline to expect

Not specified by Sedecal for remediation timelines

If the manufacturer is unresponsive

Escalate to hospital risk management or regulatory affairs
Report to FDA/recalls portal if applicable
Maintain documentation of attempts to contact Sedecal

How to prevent similar issues

Follow manual cleaning procedures precisely
Do not use water or cleaning agents beyond manual guidance
Verify device is within the affected model group before cleaning or servicing
Keep a log of all cleaning procedures and contacts

Documentation advice

Photograph labels, serial numbers, UDI, and any communications with Sedecal; retain all recall notices and hospital action plans

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Product Details

Model numbers: SM-40HF-B-D-C; 40KW.005. Sold to healthcare facilities in the United States (California, Illinois, New Jersey). Sold from unknown start date. Price not disclosed. Quoted quantity: 6 units. Brand: Sedecal. Serial numbers associated: G64274, G40012, G64597, G70742, G72764, G61804. UDI/DI: 08436046001510.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

Model SM-40HF-B-D-C; 40KW.005
Distribution: US states California, Illinois, New Jersey
Hazard: not water-resistant; improper cleaning per manual could cause problems

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

5/ 10

Affected Groups

GENERAL

Jun 10, 2025

Sedecal

Sedecal sent