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; 40KW 50C, UDI/DI 08436046001510, Serial G32487, 31414, G35462, G32657
- 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 to perform radiographic exams at a patient’s bedside. They are critical for quick imaging in acute settings.
Why This Is Dangerous
The device is not water-resistant and must be cleaned per the manual. Improper cleaning could cause safety or equipment issues.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Affects 4 units in the US. Requires immediate cessation of use and guidance from the manufacturer. No injuries reported yet.
Practical Guidance
How to identify if yours is affected
- 1) Confirm model number SM-40HF-B-D-C; 2) Check UDI 08436046001510; 3) Check serial numbers G32487, 31414, G35462, G32657; 4) Confirm distribution states CA, IL, NJ.
Where to find product info
FDA recall page and Sedecal SA notices; Manufacturer contact information will be provided by Sedecal SA.
What timeline to expect
4-8 weeks typical for recall communications, but this recall provides no specific timeframe.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer
- Escalate to hospital risk management
- Reach out to FDA recall program if needed
How to prevent similar issues
- Ensure cleaning procedures align with the manual during procurement
- Verify water-resistance ratings before purchase of imaging equipment
- Train staff on cleaning protocols for non-water-resistant devices
Documentation advice
Keep a copy of the recall notice, document serial numbers, take photos of labels, save all correspondence with Sedecal SA
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Product Details
Model numbers: SM-40HF-B-D-C; 40KW 50C Where sold: United States, California, Illinois, New Jersey When sold: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distribution in CA, IL, NJ
- Not water-resistant; cleaning per manual required
- No injuries or incidents reported
- Stop using immediately; contact Sedecal SA for instructions
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Safety Guide
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