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
- 40116, UDI/DI unknown
- 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
Mobile X-ray systems are used in hospitals for bedside imaging, enabling rapid assessment without transport. They are critical equipment in emergency and inpatient care.
Why This Is Dangerous
The device is not water-resistant and must be cleaned strictly per the manual. Improper cleaning could lead to damage or safety risks in a clinical setting.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals in CA, IL, and NJ may need to pause certain imaging workflows and coordinate with the manufacturer for replacement or remediation; the recall is active.
Practical Guidance
How to identify if yours is affected
- Check serial number 40116 on the device label
- Confirm UDI/DI status if available
- Review the recall notice and FDA page for instructions
- Coordinate with facility leadership for remediation
Where to find product info
Recall notice and FDA enforcement page linked in the article; manufacturer contact for Sedecal SA instructions
What timeline to expect
Remediation timeline varies by institution; manufacturers typically coordinate replacements or service, potentially weeks.
If the manufacturer is unresponsive
- Document all requests and responses with the manufacturer
- Escalate to the hospital’s compliance office or regulatory authorities if needed
- Consider contacting the FDA for guidance on medical device recalls
How to prevent similar issues
- Ensure cleaning procedures strictly follow the manual; do not improvise cleaning methods
- Train staff on recall procedures and device handling
- Verify device compatibility and water exposure guidelines before any cleaning
Documentation advice
Keep a log of serial numbers checked, communications with the manufacturer, and remediation steps taken
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Product Details
Model numbers: Serial Numbers 40116; UDI/DI unknown. Sold in the United States in CA, IL, NJ. Sold date and price not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- UDI/DI: unknown
- Distribution: US states CA, IL, NJ
- Hazard: not water-resistant; cleaning per manual
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Safety Guide
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