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
- 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 SA manufactures medical imaging equipment, including mobile X-ray systems used in hospitals and clinics to perform radiographic exams at the point of care.
Why This Is Dangerous
The device is not water-resistant. Cleaning must follow the manual to avoid damage or exposure risks that could affect performance.
Industry Context
This recall highlights the importance of proper cleaning guidelines for delicate radiographic equipment and the potential risks when guidance is not followed.
Real-World Impact
Facilities must cease use immediately and follow recall steps. The impact is operational disruption and potential safety concerns if cleaning is not performed per the manual.
Practical Guidance
How to identify if yours is affected
- Verify model SM-40HF-B-D-C
- Check UDI/DI 08436046001510
- Inspect serial numbers G35462, G-32753, G35480, G33111, G33721
Where to find product info
Device label for model, UDI/DI, and serial numbers. Recall notice from SEDECAL SA and FDA listing Z-0265-2026.
What timeline to expect
4-6 weeks for remedy processing is typical, but the recall notice does not specify a timeline.
If the manufacturer is unresponsive
- Escalate with hospital risk management
- Contact FDA recall helpline or local health authorities
- Document all communications with the manufacturer
How to prevent similar issues
- Only use devices with up-to-date cleaning procedures as per the manual
- Maintain access to recall notices and verification documents
- Source replacements from authorized channels
Documentation advice
Keep the recall notice, model numbers, UDI/DI, serial numbers, and all correspondence with the manufacturer.
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Product Details
Model numbers: SM-40HF-B-D-C; 40KW 55C Where sold: United States (California, Illinois, New Jersey) When sold: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model SM-40HF-B-D-C; 40KW 55C
- Distributed to CA, IL, NJ in the United States
- Not water-resistant; cleaning per manual required
- No injuries reported to date
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