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, G62066
- 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-40HF-B-D-C is a mobile X-ray system used in clinical settings to perform radiographic imaging at patients’ bedsides or in clinics. Hospitals rely on these units for diagnostic imaging in various departments. The unit in question is a 40KW, 70C EN model.
Why This Is Dangerous
The manufacturer notes the device is not water-resistant. Cleaning must be conducted per the manual. Improper cleaning could lead to safety or function issues.
Industry Context
This recall is not identified as part of a broader industry pattern in the notice.
Real-World Impact
The recall affects one unit in distribution to specific US states. Facilities must halt use and follow recall instructions to avoid potential safety or performance problems.
Practical Guidance
How to identify if yours is affected
- Verify model SM-40HF-B-D-C is in use by checking the unit label and serial G62066.
- Cross-check UDI/DI 08436046001510 on the device documentation.
- Confirm distribution location covers CA, IL, NJ.
Where to find product info
Look on the device label for model, UDI/DI, and serial numbers. The recall instructions were issued via email to consignees.
What timeline to expect
Further recall instructions from the manufacturer will specify steps and timelines.
If the manufacturer is unresponsive
- Escalate to hospital administration and biomedical engineering.
- File a formal inquiry with SEDECAL SA through official channels.
- If needed, report to relevant health authority or regulatory body.
How to prevent similar issues
- Verify IP rating or water-resistance specifications before use in clinical settings.
- Follow the manufacturer’s cleaning instructions exactly as written.
- Maintain an inventory of all units and verify serials and UDI/DI against recalls.
Documentation advice
Retain recall communications, device labels, serial numbers, and any responses from SEDECAL SA or healthcare providers.
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Product Details
Model SM-40HF-B-D-C; UDI/DI 08436046001510; Serial G62066. Distribution: US (CA, IL, NJ). Quantity: 1 unit. Sold in the US and Canada. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model SM-40HF-B-D-C; UDI/DI 08436046001510; Serial G62066
- Distribution to CA, IL, NJ in the US
- Not water-resistant; cleaning per manual required
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