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
- 40KWFXPLUS, UDI/DI 08436046002166, G75176, G75504, G76697, G78126, G78025, G78715 +13 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 40KWFXPLUS is a mobile X-ray imaging system used in hospitals and clinics to perform bedside radiographs.
Why This Is Dangerous
The device is not water-resistant and requires cleaning per the manual. Improper cleaning can lead to damage or safety concerns as described by the manufacturer.
Industry Context
This recall is not indicated as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics with the device must verify if they own an affected unit. 268 units are impacted across the US, with immediate cessation of use recommended until further instructions are provided.
Practical Guidance
How to identify if yours is affected
- Verify the device is the 40KWFXPLUS model.
- Confirm distribution in CA, IL, NJ.
Where to find product info
Check the device label and data plate for model, serial number, and UDI/DI.
What timeline to expect
Not specified in the recall notice.
If the manufacturer is unresponsive
- Escalate to hospital risk management or device vendor support.
- File a formal complaint with the CPSC if the device remains in use after steps have been communicated.
How to prevent similar issues
- Confirm water-resistance and cleaning procedures before procurement.
- Ensure staff are trained on cleaning per the manual.
- Verify device integrity after any cleaning procedure and document communication with manufacturer.
Documentation advice
Retain recall notices, email communications, serials, and data plate photos. Log all handling steps and communications with the device vendor.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- UDI/DI 08436046002166 valid
- Distribution in CA, IL, NJ
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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