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
- 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 medical imaging. It is deployed in healthcare facilities to perform radiographs at patient bedsides or in wards.
Why This Is Dangerous
The device is not water-resistant. Cleaning must follow the manual. Improper cleaning could create safety risks depending on exposure and handling during cleaning.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Healthcare facilities must halt use of this unit to avoid potential safety issues related to improper cleaning. Impact on operations may include sourcing guidance from the manufacturer and temporary imaging delays.
Practical Guidance
How to identify if yours is affected
- Verify model SM-40HF-B-D-C on the device label
- Check UDI/DI 08436046001510
- Check Serial Number G37528
- Confirm distribution to CA, IL, NJ
- Review the recall notice received by email and FDA page
Where to find product info
Serial number and model are located on the device label near the power/data plate. UDI/DI is listed on the same label.
What timeline to expect
No remedy timeline is provided in the notice. Follow manufacturer instructions for next steps and monitor FDA recall updates.
If the manufacturer is unresponsive
- Document all contact attempts with SEDECAL SA
- File a safety report with the FDA if no response after a reasonable period
- Consult your hospital risk management team for escalation
How to prevent similar issues
- Do not use devices that are not water-resistant unless manufacturer-approved.
- Follow the cleaning protocol exactly as described in the manual.
- Verify device identifications before any cleaning procedures.
- For future acquisitions, check IP ratings and cleaning guidelines in the manual
Documentation advice
Keep the recall email, the UDI/DI and serial numbers, and all communications with SEDECAL SA. Photograph labels and store copies of all official notices.
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Product Details
Model numbers: SM-40HF-B-D-C; UDI/DI: 08436046001510; Serial Numbers: G37528 Where sold/distributed: United States — California, Illinois, New Jersey When sold: Recall Date 2025-06-10; Date sold not specified Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model SM-40HF-B-D-C
- Serial Number G37528
- Distribution: CA, IL, NJ
- Recall Date 2025-06-10; Status: ACTIVE
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Safety Guide
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