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-40HF-B-D-C, UDI/DI 08436046001510, G33585
- 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
A mobile X-ray system is used in hospitals and clinics to perform radiographic imaging at patient bedsides and other locations outside the fixed radiography room.
Why This Is Dangerous
Not water-resistant. Cleaning must follow the manual. Improper cleaning could lead to damage or functional issues that affect safe operation.
Industry Context
This recall is not presented as part of a broader industry pattern in the provided information.
Real-World Impact
Facility downtime may occur as the unit is removed from service until guidance is provided.
Practical Guidance
How to identify if yours is affected
- Verify model SM-40HF-B-D-C and check UDI/DI 08436046001510 on the unit label.
- Check serial number G33585.
- Consult the recall notice for instructions and the FDA recall page.
Where to find product info
Identifiers can be found on the device label near the control panel; UDI/DI and serial number are listed in the recall details.
What timeline to expect
Not specified by the recall; expect manufacturer instructions and possible service actions.
If the manufacturer is unresponsive
- Document attempts to contact Sedecal SA.
- Consult your healthcare provider for interim guidance.
How to prevent similar issues
- Always follow the manufacturer cleaning guidelines exactly as written.
- Do not expose imaging equipment to water or liquids beyond what is specified.
- Implement a standard cleaning protocol for medical imaging devices.
- Confirm any cleaning products used are approved by the manufacturer.
Documentation advice
Keep a copy of the recall notice, note unit serials, and communications with Sedecal SA.
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Product Details
Model SM-40HF-B-D-C; 40KW 55C/60C; Distribution to CA, IL, NJ in the US. Recall date 2025-06-10. Status: Active. Quantity: 1 unit. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model SM-40HF-B-D-C
- Not water-resistant; cleaning per manual
- Distribution CA, IL, NJ
- No injuries reported
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Safety Guide
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