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.889, UDI/DI 08436046002166, G77146
- 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 Mobile X-ray System is used in clinical settings for radiographic imaging. It is a specialized medical device that helps diagnose and monitor patients.
Why This Is Dangerous
The device is not water-resistant and must be cleaned strictly according to the manual. Improper cleaning could lead to unintended consequences as outlined by the manufacturer.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
The immediate impact is operational disruption for facilities using the device. There is a potential safety risk if cleaning is not performed per protocol, but no injuries are reported in the recall notice.
Practical Guidance
How to identify if yours is affected
- 1) Locate the device label on the system for model numbers.
- 2) Verify model 40KWFXPLUS.889.
- 3) Check serial number G77146 and UDI/DI 08436046002166.
Where to find product info
Recall details are provided via email by Sedecal SA and are available in the FDA enforcement report Z-0250-2026.
What timeline to expect
There is no specific timeline provided for remedy processing beyond the recall notice.
If the manufacturer is unresponsive
- Escalate to hospital or facility administration.
- Contact Sedecal SA for documentation and follow-up.
- If issues remain unresolved, consider filing a complaint with the appropriate regulatory agency.
How to prevent similar issues
- Always follow the cleaning instructions in the manual.
- Do not expose non-water resistant devices to cleaning agents or processes not approved in the manual.
- Establish a protocol for handling recalls and ensure staff are trained on follow-up actions.
Documentation advice
Save the recall notice email, device label, serial numbers, and any correspondence with the manufacturer or healthcare provider.
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Product Details
Model: 40KWFXPLUS.889; UDI/DI: 08436046002166; Serial Number: G77146. Distribution: United States, states CA, IL, NJ. Recall Date: 2025-06-10. Status: ACTIVE. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Serial number G77146
- Distribution: CA, IL, NJ (USA)
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Safety Guide
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