Quick Facts at a Glance
- Recall Date
- June 10, 2025
- Hazard Level
- HIGH
- AI Risk Assessment
- LOW
- 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-710CW, UDI/DI 08436046002166, G83204, G82622, G79677, G79194, G82129, G79632 +6 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 Sedecal SA 40KWFXPLUS-710CW is a mobile X-ray imaging system used in medical facilities for radiographic diagnostics. Such devices are typically mounted on wheels for transport within hospitals.
Why This Is Dangerous
The device is not water-resistant. Cleaning must follow the manual strictly to avoid adverse consequences from improper cleaning, which can compromise safety and performance.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Hospitals and clinics may need to adjust cleaning procedures and recall communications. The immediate action is to stop use and follow manufacturer instructions to avoid potential equipment damage or patient safety risks.
Practical Guidance
How to identify if yours is affected
- 1. Locate model number on the device: 40KWFXPLUS-710CW.
- 4. Confirm distribution region: CA, IL, NJ in the US.
Where to find product info
Refer to the FDA recall page for details: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0251-2026
What timeline to expect
No timeline is provided for refunds or replacements in the notice. Follow the manufacturer's recall instructions and FDA updates.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- File a complaint with FDA if manufacturer is unresponsive.
- Consult hospital risk management for guidance on device removal and replacement options.
How to prevent similar issues
- Adhere strictly to cleaning instructions in the manual.
- Do not use water on non-water-resistant devices.
- Establish a standard cleaning protocol for mobile X-ray systems and train staff accordingly.
- Verify device specifications before cleaning to avoid inadvertent exposure.
Documentation advice
Keep a copy of the recall notice, list of affected serial numbers, corresponding UDI, and all communications with Sedecal SA for records.
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Product Details
Model numbers: 40KWFXPLUS-710CW; UDI/DI 08436046002166; Serial Numbers: G83204, G82622, G79677, G79194, G82129, G79632, G79837, G79924, G84490, G84640, G79699, G84605. Where sold: United States, distributed to California, Illinois, and New Jersey. When sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model 40KWFXPLUS-710CW
- Notices sent by email to consignees
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Safety Guide
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