Quick Facts at a Glance
- Recall Date
- June 10, 2025
- Hazard Level
- HIGH
- Brand
- Sedecal SA
- 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 SA
- Product type
- Mobile X-ray System
- Model numbers
- SM-32HF-Batt; 32KW ANALOG, Mobile X-ray System, UDI/DI 08436046001466
- 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 SM-32HF-Batt is a mobile X-ray system used in clinical imaging settings. It is designed for point-of-care radiography in hospitals or clinics.
Why This Is Dangerous
The unit is not water-resistant and requires cleaning only per the manual. Improper cleaning could cause equipment damage or safety hazards to patients and staff.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Facilities must halt use of affected devices and follow the manufacturer's recall instructions. No injuries have been reported, but the impact includes potential disruption to imaging services and additional steps for validation.
Practical Guidance
How to identify if yours is affected
- Verify model SM-32HF-Batt is on site
- Check UDI/DI 08436046001466 and serial numbers listed
- Confirm the device’s cleaning procedure aligns with the manual
Where to find product info
Recall notices were sent by email to consignees; FDA recall page Z-0256-2026 contains details
What timeline to expect
Manufacturers typically complete replacements or repairs within weeks to a few months, depending on availability
If the manufacturer is unresponsive
- Document communication attempts with Sedecal SA
- File a notice with the local hospital risk management team
- Escalate to FDA recall office if no response after 4 weeks
How to prevent similar issues
- When purchasing imaging equipment, verify water-resistance and cleaning protocols
- Keep manuals accessible and train staff on approved cleaning procedures
- Monitor recall databases for updates on medical devices
- Ask manufacturers about post-market service and repair options
Documentation advice
Keep the recall notice, serial numbers, UDI/DI, and all correspondence with Sedecal SA; document service history and downtime during remediation
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Product Details
Model: SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system UDI/DI: 08436046001466 Serial Numbers: G-33344, G29404, G29407, G30258, G30236, G63124, G60169, G26234, G26284, G25734, G38069, G-40590, G41143, G62020, G69393, G38082, G41163, G60166, G26244 Sold in: United States (states of California, Illinois, New Jersey) Quantity: 22 units Recall date: 2025-06-10 Status: Active Notes: UDI/DI and serial numbers listed are those associated with affected units
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model SM-32HF-Batt; 32KW ANALOG Mobile X-ray System
- Distributed to CA, IL, NJ
- Recall date 2025-06-10; status Active
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Safety Guide
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