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
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, G-33103, G35422, G35504, G33127, G33646
- 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
The Sedecal SM-40HF-B-D-C is a mobile X-ray system used in clinical imaging. It provides portable imaging capabilities in hospitals and clinics.
Why This Is Dangerous
The device is not water-resistant. Cleaning must follow the manual to avoid potential safety issues related to improper cleaning.
Industry Context
This recall is not described as part of a broader industry pattern.
Practical Guidance
How to identify if yours is affected
- Confirm device model SM-40HF-B-D-C and check serial numbers against the list (G-33103, G35422, G35504, G33127, G33646)
- Check for UDI/DI 08436046001510 on the device label
- Verify distribution location (US states CA, IL, NJ) or consignees in the recall notice
Where to find product info
Recall notices and model/UDI numbers are in Sedecal's communications and the FDA enforcement report (Z-0267-2026)
What timeline to expect
Recall instructions will be provided by the manufacturer; replacements or refunds, if offered, will follow Sedecal's timeline.
If the manufacturer is unresponsive
- Document all communications with Sedecal SA
- File a report with the hospital risk management team
- Contact the local health authority or FDA for guidance if the manufacturer is unresponsive
How to prevent similar issues
- Always follow the cleaning procedures exactly as written in the manual
- Avoid exposing the device to water or liquids not specified in the manual
- Regularly review vendor recall notices for medical imaging equipment
Documentation advice
Keep all recall notices, emails, serial numbers, UDI/DI, and distribution lists; retain communications with Sedecal SA for future reference
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Product Details
Model numbers: SM-40HF-B-D-C; 40KW 55G Mobile X-ray System. Distribution: United States (CA, IL, NJ). Sold/used: Unknown. Quantity: 5 units. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model SM-40HF-B-D-C; 40KW 55G
- Not water-resistant; cleaning per manual required
- No injuries reported
- Distribute in CA, IL, NJ (US)
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Safety Guide
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