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, G37587
- 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 Mobile X-ray system is used in healthcare settings for portable imaging. Medical professionals value this device for its mobility and efficiency in patient care.
Why This Is Dangerous
The lack of water resistance means that liquids can enter sensitive internal components, causing electrical failures and potential patient safety issues if proper cleaning procedures are not followed.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using the device immediately, which could disrupt medical services until a replacement or guidance is provided.
Practical Guidance
How to identify if yours is affected
- Check the model number against the recalled product information.
- Verify the serial number on your device matches the recalled units.
- Look at any recent emails from SEDECAL for instructions regarding the recall.
Where to find product info
The serial number can typically be found on the back or underside of the device. Consult the user manual for exact locations.
What timeline to expect
4-6 weeks for refund processing from SEDECAL after following their instructions.
If the manufacturer is unresponsive
- Document your attempts to contact SEDECAL.
- Follow up with the FDA if you receive no response within two weeks.
How to prevent similar issues
- Always adhere to cleaning guidelines specified by the manufacturer.
- Ensure devices used in medical settings are inspected regularly for compliance with safety standards.
Documentation advice
Keep all correspondences, receipts, and photos of the product to document your claims or issues.
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Product Details
Model Number: SM-40HF-B-D-C; UDI/DI: 08436046001510; Serial Numbers: G37587; Sold in: CA, IL, NJ; Recall Date: June 10, 2025.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model Number: SM-40HF-B-D-C
- Sold in: CA, IL, NJ
- Recall Date: June 10, 2025
- Immediate stop use required
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Safety Guide
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