Quick Facts at a Glance
- Recall Date
- June 10, 2025
- Hazard Level
- HIGH
- Brand
- Sedecal
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 3 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
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.002, UDI/DI 08436046002166, G73508, G73512, G71323, G72419, G78910, G72425 +2 more
- Sold at
- Multiple Retailers
- 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 40KWFXPLUS.002 is a mobile X-ray imaging system used in clinics and hospitals to perform radiographs at patient bedsides.
Why This Is Dangerous
The device is not water-resistant and must be cleaned strictly per the manual. Improper cleaning could lead to equipment damage or unsafe conditions as described by the manufacturer.
Industry Context
This recall is not identified as part of a broader industry pattern.
Real-World Impact
Immediate use of the affected devices is not advised, which could affect patient care workflows and require reallocation of imaging resources.
Practical Guidance
How to identify if yours is affected
- Verify model number 40KWFXPLUS.002 on the device label.
- Check for the UDI 08436046002166.
Where to find product info
Device label, manual, and the FDA recall page (Z-0247-2026).
What timeline to expect
4-8 weeks for refunds or replacements under typical recall handling.
If the manufacturer is unresponsive
- Document all contact attempts
- Escalate to hospital compliance or risk management if the manufacturer is slow to respond
How to prevent similar issues
- Always follow the manual for cleaning.
- Do not use water on non-water-resistant equipment.
- When purchasing medical imaging equipment, verify water-resistance and cleaning guidelines.
Documentation advice
Save recall emails, keep serial numbers, photos of labels, and all communications with Sedecal SA or healthcare providers.
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Product Details
Model Number 40KWFXPLUS.002. Mobile X-ray system. Eight units distributed in the United States in California, Illinois, and New Jersey.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distributed in CA, IL, NJ (US)
- Notification method: Email
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Safety Guide
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