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
- 40KWMOBILE3.899
- 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
Mobile X-ray systems are used in hospitals and clinics to perform imaging at patient bedsides or transport corridors. They enable rapid imaging in critical care or emergency settings and are essential for timely diagnoses.
Why This Is Dangerous
The device is not water-resistant. Cleaning must follow the manual precisely. Improper cleaning could damage the device, potentially affecting imaging performance or electrical integrity.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
A single-unit recall with no injuries reduces immediate patient risk but could disrupt imaging services at facilities using the device until guidance is provided.
Practical Guidance
How to identify if yours is affected
- Confirm model number 40KWMOBILE3.899 on the device data plate.
- Check serial number G64852.
- Verify it was distributed to CA, IL, or NJ.
Where to find product info
Refer to the FDA recall page linked in the notice for official identifiers and remedy steps.
What timeline to expect
Remedy processing timelines are not specified. Facilities should follow manufacturer guidance promptly.
If the manufacturer is unresponsive
- Escalate to hospital risk management.
- Contact FDA CDRH if the company remains unresponsive after outreach.
How to prevent similar issues
- Strictly follow the manual for cleaning and water exposure safety.
- Establish a formal cleaning verification process for all portable imaging devices.
- Document all cleaning steps and any deviations.
Documentation advice
Keep the recall notification, model and serial numbers, correspondence with Sedecal SA, and any service records related to the device.
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Product Details
Model numbers: 40KWMOBILE3.899. Sold in the United States to consignees in CA, IL, and NJ. Sold since: Distribution noted; recall date 2025-06-10. Original price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distribution: CA, IL, NJ
- No injuries reported
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Safety Guide
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