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
- 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 SM-40HF-B-D-C is a mobile X-ray system used in clinical imaging. The recall concerns cleaning procedures and water resistance.
Why This Is Dangerous
Improper cleaning or water exposure could lead to safety issues or equipment damage per the manufacturer’s caution.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Clinicians must halt use until guidance is provided. Hospitals may need to segregate affected units to prevent use and communicate with patients about the recall.
Practical Guidance
How to identify if yours is affected
- Verify model SM-40HF-B-D-C
- Confirm distribution in CA, IL, NJ
Where to find product info
FDA recall enforcement page and Sedecal’s official communications
What timeline to expect
No timeline provided for remedy; follow instructions in recall notice
If the manufacturer is unresponsive
- Document all communications with Sedecal SA
- Escalate to FDA recall contact if needed
How to prevent similar issues
- Do not clean devices with water or liquids not per manual
- Train staff on cleaning procedures per the manual
- Maintain an updated inventory of all mobile X-ray systems and verify recall status before use
Documentation advice
Keep copies of recall notices, serial number lists, and communications with the manufacturer for records
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Product Details
Model numbers: SM-40HF-B-D-C Units recalled: 27 Where sold/distributed: United States, CA, IL, NJ Sold to: Consignees (not specified as retail purchasers) Classification: Class II Serial numbers (sample): G31761, G30761, G32587, G32577, G31065, G33581, G30808, G30762, G29873, G30156, G30173, G30952, G30689, G33004, G30155, G30025, G35450, G35620, G30570 Udi/DI: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model SM-40HF-B-D-C
- Serial numbers list includes G31761, G30761, G32587, G32577, G31065, G33581
- Distributed in CA, IL, NJ (US)
- Classification: Class II
- Hazard: not water-resistant; cleaning per manual required
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Safety Guide
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