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-40HF-B-D-C, UDI/DI 08436046001510, G35611, G37536, G37588, G37490
- 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
This is a mobile X-ray imaging system used in hospitals and clinics to perform radiographs at point of care.
Why This Is Dangerous
Not water-resistant. Cleaning must follow the manual. Improper cleaning could affect device integrity or performance.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Facilities must stop using the device immediately. Without a remedy timeline, there may be imaging delays and operational disruption.
Practical Guidance
How to identify if yours is affected
- Confirm model SM-40HF-B-D-C and verify UDI 08436046001510
- Check serial numbers G35611, G37536, G37588, G37490
- Confirm recall status on FDA page Z-0270-2026
- Review cleaning procedures in the operator manual
Where to find product info
FDA enforcement page for recall Z-0270-2026 and Sedecal notices
What timeline to expect
Remedy timeline not specified; expect updates from Sedecal and FDA within weeks to months
If the manufacturer is unresponsive
- Document all inquiries to Sedecal SA
- Escalate to FDA recall contacts if no response within 2-4 weeks
- Consider medical device regulatory counsel if needed
How to prevent similar issues
- Always follow the manual cleaning procedures for equipment
- Ensure water exposure is avoided on non-water-resistant devices
- Verify device specifications before cleaning or servicing
- Select replacement devices with clear water-resistance and cleaning protocols
Documentation advice
Keep the recall notification, record model/UDI/serial numbers, document communications with Sedecal SA or providers
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Product Details
Model numbers: SM-40HF-B-D-C Description: 40KW 55C/60C Mobile X-ray system Sold in: United States, CA IL NJ When sold: Unknown 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 required
- Distribution: CA, IL, NJ
- Status: Active (Z-0270-2026) at FDA
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Safety Guide
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