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-Batt, UDI/DI 08436046001114, G24948, G25512, C25673, 25901, G25771, G26990 +3 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
Sedecal SA produces radiology equipment including mobile X-ray systems used in hospitals and clinics to image patients at bedside or in transport.
Why This Is Dangerous
The device is not water-resistant and requires cleaning per the manual. Improper cleaning could damage the unit or affect safety during operation.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to quarantine these units and review cleaning protocols. The impact is operational and safety-oriented rather than a consumer product hazard.
Practical Guidance
How to identify if yours is affected
- Confirm the device is a SM-40HF-Batt 40KW analog Mobile X-ray System
- Check UDI/DI 08436046001114
- Note distribution: CA, IL, NJ in the US
- Review date: recall dated 2025-06-10
Where to find product info
Device labels show model, UDI/DI, and serial numbers; recall notice available on FDA enforcement page
What timeline to expect
Refunds or replacements are not specified; manufacturers typically resolve within weeks to months after confirmation
If the manufacturer is unresponsive
- Document all communications with Sedecal SA
- Escalate to hospital procurement and regulatory contacts if needed
- Consult FDA or patient safety authorities if no response
How to prevent similar issues
- Ensure cleaning steps match the manual specifications
- Avoid using equipment after cleaning until approved
- Keep a log of cleaning procedures and dates for each device
- Verify UDI and serial numbers against recall list before use
- Consider alternative interim imaging options until replacement guidance is issued
Documentation advice
Record model, UDI, serial numbers, distribution locations, recall notices, and all correspondence with Sedecal SA.
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Product Details
Model numbers: SM-40HF-Batt. UDI/DI: 08436046001114. Serial numbers: G24948, G25512, C25673, 25901, G25771, G26990, G25506, G22189, G30240. Sold in the US: CA, IL, NJ. Recall date: 2025-06-10. Status: ACTIVE. Quantity: 9 units. Manufacturer: Sedecal SA.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distribution in CA, IL, NJ (US)
- Model SM-40HF-Batt; UDI/DI 08436046001114
- Not water-resistant; cleaning per manual
- Recall date 2025-06-10; Status ACTIVE
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Safety Guide
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