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
- UDI/DI 08436046002166, G72770
- 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 40KW-FX.899 is a mobile X-ray system used in clinical settings for point-of-care imaging. It requires periodic cleaning according to the user manual.
Why This Is Dangerous
The device is not water-resistant. Cleaning must follow the manual to avoid damage or safety hazards. Improper cleaning could compromise device function or patient safety.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics with the device must halt use until instructed by the manufacturer. The issue could disrupt imaging workflows and require reallocation of equipment.
Practical Guidance
How to identify if yours is affected
- Verify unit is the 40KW-FX.899 model.
- Check UDI/DI 08436046002166 and serial G72770.
- Confirm distribution states CA, IL, NJ.
Where to find product info
Recall notice and FDA enforcement page linked above. Manufacturer communications and device manual.
What timeline to expect
No specific resolution timeframe provided. Recalls typically depend on manufacturer and facility readiness.
If the manufacturer is unresponsive
- Document all communications with Sedecal SA.
- Escalate to hospital risk management or patient safety office if responses are delayed.
- File a complaint with the FDA if the manufacturer does not respond within a reasonable period.
How to prevent similar issues
- Verify cleaning protocols before procurement.
- Ensure staff follows the manual for cleaning and water exposure limitations.
- Request written recall instructions and keep them on file.
- Consider safer alternatives or additional protective measures for future purchases.
Documentation advice
Retain all recall notices, email communications, and any responses from Sedecal SA. Record unit identifiers and dates of communications.
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Product Details
Model numbers: UDI/DI 08436046002166; Serial Numbers: G72770. Sold at: Unknown. When sold: Unknown. Price: Unknown. Recall date: 2025-06-10. Quantity: 1 unit. Country of origin: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model UDI/DI 08436046002166; Serial G72770
- Hazard: not water-resistant; cleaning per manual
- Distribution: US CA, IL, NJ
- Status: Active (FDA Z-0245-2026) Manufacturer: Sedecal SA
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Safety Guide
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