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, 40KW.002, UDI/DI 08436046001510, G39544, G62558, G71736, G40116, G65568 +1 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
The mobile X-ray system is a portable imaging device used in hospitals to perform radiographs at patient bedside or in various clinical settings.
Why This Is Dangerous
Not water-resistant. Cleaning must follow the manual. Improper cleaning may damage the unit or affect performance.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Equipment damage or malfunction could disrupt imaging services and require service or replacement; no injuries reported yet.
Practical Guidance
How to identify if yours is affected
- 1. Confirm model SM-40HF-B-D-C; 40KW.002.
- 3. Confirm distribution to CA, IL, NJ.
- 4. If affected, stop use and contact the manufacturer for instructions.
Where to find product info
Serial numbers appear on the device label and in the user manual. UDI: 08436046001510.
What timeline to expect
Not specified by the manufacturer.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Escalate to hospital administration or procurement.
- File a report with the FDA if the company remains unresponsive.
How to prevent similar issues
- Ensure cleaning procedures follow the manual for all similar equipment.
- Avoid using devices that have damaged seals or water exposure.
- Review and train staff on cleaning protocols and device handling.
Documentation advice
Keep all recall notices, emails, and manufacturer instructions. Save serial numbers and model details for your records.
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Product Details
Model numbers: SM-40HF-B-D-C; 40KW.002. Distribution: US consignees in CA, IL, NJ. Recall date: 2025-06-10. Quantity: 6 units. Sold at: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model SM-40HF-B-D-C; 40KW.002
- Distributed to CA, IL, NJ
- Hazard: not water-resistant; improper cleaning may damage or affect operation
- No injuries reported
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Safety Guide
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