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
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
- UDI/DI 08436046002166, Serial Numbers: G71453, G70953, G70930, G70537, G70757, G70797, G70275 +12 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 40KWFX Mobile X-ray System is a portable medical imaging device used in clinical settings to perform radiographic exams at patient bedsides or exam rooms. Hospitals purchase these systems for rapid diagnostics and reduced patient transport.
Why This Is Dangerous
The device is not water-resistant. Cleaning must follow the manual exactly to prevent adverse outcomes. Improper cleaning could compromise device function or patient safety.
Industry Context
This recall is not described as part of a broader industry pattern. No mass incidents are reported in the data.
Real-World Impact
Healthcare facilities must halt use of affected units, verify serial numbers, and coordinate with Sedecal for remediation. The situation could cause operational delays and potential administrative burdens while awaiting replacements or refunds.
Practical Guidance
How to identify if yours is affected
- Locate the device label for UDI/DI 08436046002166
- Check if the unit was distributed to CA, IL, NJ
Where to find product info
Recalls and identifiers are listed in the FDA enforcement report linked in the source data. The device label or owner manual may also show UDI/DI and serial numbers.
What timeline to expect
Remedies, including refunds or replacements, are typically processed in 4-6 weeks after eligibility is confirmed.
If the manufacturer is unresponsive
- Document all correspondence with Sedecal and the healthcare facility
- Escalate to the appropriate medical device regulator if needed
How to prevent similar issues
- Verify water resistance and cleaning instructions before purchasing any medical imaging device
- Ensure staff receive training on proper cleaning per the manufacturer manual
- Keep all recall notices and manuals accessible for reference
Documentation advice
Keep the recall notice, serial numbers, UDI/DI, and all correspondence. Photograph labels and document dates.
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Product Details
Model numbers include UDI/DI 08436046002166 and multiple serial numbers such as G71453, G70953, G70930, G70537, G70757, G70797, G70275, G71257, G71983, G71975, G71467, G69702, G71440, G71329, G70244, G70955, G71462, G71320, G71451. 55 units recalled. Distribution limited to the United States, specifically California, Illinois and New Jersey. Recall date 2025-06-10. Status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model/UDI: UDI/DI 08436046002166
- Distribution: CA, IL, NJ
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Safety Guide
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