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, 08436046001510, G36566
- 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
This is a mobile X-ray imaging system used in clinical settings to perform radiographic exams at the point of care. The unit is designed for hospital or clinic use and is part of Sedecal’s medical imaging line.
Why This Is Dangerous
The device is not water-resistant. Cleaning must follow the manual exactly. Improper cleaning can lead to damage or other safety concerns as described by the manufacturer.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
A single unit recall affects clinical workflows and requires immediate action to prevent potential equipment damage or safety issues related to cleaning procedures.
Practical Guidance
How to identify if yours is affected
- Verify model SM-40HF-B-D-C on the device label.
- Check UDI/DI 08436046001510.
- Check serial number G36566.
- Confirm distribution in CA, IL, NJ.
Where to find product info
Look for the data plate on the device or consult Sedecal’s recall communications and the FDA recall page.
What timeline to expect
Remedies or replacements are communicated by Sedecal; processing timelines are not specified in the recall.
If the manufacturer is unresponsive
- Document all recall notices and attempts to contact Sedecal SA.
- Escalate to the FDA recall page for guidance if the manufacturer is unresponsive.
How to prevent similar issues
- When buying medical imaging equipment, verify cleaning protocols and the water-resistance rating.
- Follow all manufacturer cleaning instructions strictly.
- Maintain an internal log of recall communications.
Documentation advice
Keep copies of the recall notice, emails, and any responses from Sedecal SA. Save device identifiers (model, UDI, serial) for verification.
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Product Details
Model numbers: SM-40HF-B-D-C; 40KW CANON READY.005. Location: US distribution in CA, IL, NJ. Sold in the United States. UDI/DI: 08436046001510. Serial numbers: G36566. Quantity: 1 unit. Price: Unknown. Sold at: Unknown retail channels.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model SM-40HF-B-D-C
- Serial number G36566
- Distribution: US (CA, IL, NJ)
- Recall date: 2025-06-10 (UTC) Life-cycle status: ACTIVE
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Safety Guide
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