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, G-33126, G31259, G35641, G35630, G35718, G37357
- 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 Sedecal SM-40HF-B-D-C is a mobile X-ray system used in clinical settings to image patients at the point of care. It is designed for hospital use and requires regular cleaning per the manual.
Why This Is Dangerous
The device is not water-resistant. Cleaning must adhere to the manual to prevent potential safety or performance issues.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The impact is limited to six units. Hospitals and clinics with the affected devices should follow recall instructions to avoid risk.
Practical Guidance
How to identify if yours is affected
- Verify model SM-40HF-B-D-C and Canon Ready 40KW description on the unit label.
- Compare against the recall list in the FDA notification.
Where to find product info
Check the unit data plate and the manufacturer's recall notification. See FDA enforcement page linked in the recall.
What timeline to expect
Refunds or replacements typically take 4-8 weeks after submission, depending on the provider.
If the manufacturer is unresponsive
- Escalate to hospital administration and the device distributor.
- File a formal complaint with the manufacturer and, if needed, with the relevant regulatory body.
How to prevent similar issues
- Ensure any future cleaning follows the manual exactly.
- Verify water-resistance and cleaning requirements before purchase or deployment in a clinical setting.
- Maintain a log of all recalls for hospital equipment.
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Product Details
Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system. Sold in the US: CA, IL, NJ. When sold: Unknown. Price: Unknown. UDI/DI: 08436046001510. Serial numbers include G-33126, G31259, G35641, G35630, G35718, G37357.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model SM-40HF-B-D-C
- 40KW Canon Ready, Mobile X-ray System
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Safety Guide
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