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
- SM-50HF-B-D-C, 50KW 50G, UDI/DI 08436046001527, 151248, G23340, C05006-W, G22215, G27497/584 +3 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
Sedecal Easy Moving Plus is a portable, battery-powered mobile X-ray system used in hospitals and clinics for bedside imaging.
Why This Is Dangerous
The device is not water-resistant and must be cleaned strictly according to the manual. Improper cleaning could lead to damage or safety concerns during clinical use.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Hospitals may need to isolate affected units, adjust cleaning protocols, and coordinate with Sedecal for guidance. The recall affects eight units, potentially increasing downtime and operational disruption.
Practical Guidance
How to identify if yours is affected
- Verify device model SM-50HF-B-D-C and KW rating 50G
- Check UDI/DI 08436046001527
Where to find product info
FDA recall page and Sedecal communications to consignees
What timeline to expect
No specific replacement or refund timeline is provided
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File a formal complaint with FDA if guidance is not provided within a reasonable period
- Document all communications with Sedecal and the institution
How to prevent similar issues
- Strictly follow manual cleaning instructions for all Sedecal X-ray systems
- Do not use or clean with water if the manual restricts moisture exposure
- Implement a standard operating procedure for cleaning in radiology departments
Documentation advice
Keep recall notice, purchase records, serials, UDI, and all communication with Sedecal and healthcare providers for liability and warranty purposes
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model numbers and identifiers: SM-50HF-B-D-C; 50KW 50G. UDI/DI 08436046001527. Serial numbers listed: 151248. Other identifiers include G23340, C05006-W, G22215, G27497/584, 7034, G25402, G25910. Quantity: 8 units. Distribution: United States in CA, IL, NJ. Sold/used in healthcare settings. No price information provided. Sold in the US market; recall date 2025-06-10. Status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 8 total units recalled
- Model numbers: SM-50HF-B-D-C; 50KW 50G
- Distributed in CA, IL, NJ (US)
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.