Quick Facts at a Glance
- Recall Date
- June 10, 2025
- Hazard Level
- HIGH
- Brand
- Sedecal
- 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
- Product type
- Mobile X-ray system
- Model numbers
- 40KWFXPLUS.004, G84489, G84504, G84589
- 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 Sedecal Mobile X-ray system is used in clinical settings for diagnostic imaging. It is designed for mobility within a facility.
Why This Is Dangerous
Not being water-resistant and requiring strict cleaning per the manual can lead to unsafe conditions if cleaning is improper, potentially affecting device operation or patient safety.
Industry Context
This recall is not identified as part of a broader industry pattern in the provided data.
Real-World Impact
Limited to 3 units with specific distribution. Hospitals and clinics must verify model/serials and implement the recall instructions promptly to prevent potential safety issues.
Practical Guidance
How to identify if yours is affected
- Check model number 40KWFXPLUS.004
- Inspect serial numbers G84489, G84504, G84589
- Confirm recall notice and instructions from Sedecal SA or FDA page
Where to find product info
FDA recall page and Sedecal SA communications; recall number Z-0248-2026
What timeline to expect
Refunds or replacements, if offered, typically take weeks to process
If the manufacturer is unresponsive
- Document all communications with Sedecal SA
- Escalate to the FDA if the company is unresponsive
- Consider contacting healthcare facility risk management for further guidance
How to prevent similar issues
- Verify water-resistance specs before use
- Monitor for recall updates from Sedecal SA and FDA
Documentation advice
Keep the recall notice, serial numbers, model number, and all correspondence; document instances of non-compliance or issues during cleaning.
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Product Details
Model: 40KWFXPLUS.004. Serial numbers: G84489, G84504, G84589. Sold in the United States proximately in CA, IL, and NJ. Quantity: 3 units. Recall date: 2025-06-10. Report date: 2025-10-29. Status: ACTIVE. Brand: Sedecal SA. Category: Health & Personal Care / Medical Devices.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Serial numbers G84489, G84504, G84589
- Distributions: CA, IL, NJ
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Safety Guide
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