Quick Facts at a Glance
- Recall Date
- June 10, 2025
- Hazard Level
- HIGH
- Brand
- SEDECAL SA
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 3 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
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 SA
- Product type
- Mobile X-ray System
- Model numbers
- SM-40HF-B-D-C, UDI/DI 08436046001510, G13768, G36626, G62493, G39518, G61725, G36211 +8 more
- 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 SM-40HF-B-D-C is a mobile X-ray unit rated at 40 kW intended for use in healthcare facilities.
Why This Is Dangerous
The unit is not water-resistant. Cleaning must follow the manual to avoid adverse outcomes from improper cleaning.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Immediate cessation of use to prevent potential damage or safety events; no injuries reported in the recall documentation.
Practical Guidance
How to identify if yours is affected
- Verify model SM-40HF-B-D-C is in use.
- Check for UDI 08436046001510 on labeling.
Where to find product info
Label on the equipment and the operator's manual; FDA recall page linked in recall notice
What timeline to expect
Manufacturer-led remediation timelines typically range 4-8 weeks for refunds or replacements.
If the manufacturer is unresponsive
- Document all communications with the manufacturer
- File a complaint with the FDA if no remedy is offered in a timely fashion
How to prevent similar issues
- Strictly follow the user manual for cleaning; avoid liquids near electrical components
- Consider upgrading to water-resistant housings or protective coverings where applicable
- Regularly review manufacturer recalls for installed equipment
Documentation advice
Keep the recall notice, all emails, serial numbers, model numbers, and any correspondence with Sedecal SA for records.
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Product Details
Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system. Distribution: 14 units in US (CA, IL, NJ). Sold in the United States. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model SM-40HF-B-D-C; 40KW 70C
- Distribution in CA, IL, NJ
- Hazard: not water-resistant; improper cleaning consequences
- Notification method: Email to consignees
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Safety Guide
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