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, PETS
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
- UDI/DI 08436046001510, Serial Numbers: 31526
- 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
This is a mobile X-ray imaging system used in clinical settings to perform radiographic exams at patient bedsides or portable environments.
Why This Is Dangerous
Water exposure or improper cleaning could compromise function or safety of the imaging system, potentially affecting performance.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
A single-unit recall with a high-hazard potential pending proper cleaning guidance; healthcare facilities should follow instructions to avoid equipment damage or unsafe operation.
Practical Guidance
How to identify if yours is affected
- 1. Locate the unit and verify the model SM_40HF_BDC.
- 2. Check the UDI/DI 08436046001510 and serial number 31526.
- 3. Compare with recall notice on FDA page Z-0286-2026.
Where to find product info
Recall notice and FDA enforcement page. Manufacturer contact via SEDECAL SA.
What timeline to expect
Refund or replacement timelines are not specified in the notice.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer.
- Escalate to the hospital risk management or incident reporting if no response within 4-6 weeks.
How to prevent similar issues
- Ensure cleaning protocols explicitly match the manual.
- Verify device water-resistance specifications before use.
- Keep updated with supplier recall notices for medical imaging equipment.
- DocumentationAdviceStart a file with device serial, model, UDI, and correspondence.
Documentation advice
Maintain copies of the recall notice, manufacturer instructions, and any corrective action taken by the facility.
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Product Details
Model numbers: UDI/DI 08436046001510; Serial Numbers: 31526. Distribution: United States (CA, IL, NJ). Sold from unknown date. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Cleaning must follow manual
- Distribution in CA, IL, NJ
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Safety Guide
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