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, G65281, G60407, G65682, G64582, G64789, G70752 +13 more
- 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 and clinics to perform bedside radiography, enabling imaging without transporting patients.
Why This Is Dangerous
Not water-resistant and cleaning must follow the manual. Improper cleaning can cause damage or safety issues as described by the manufacturer.
Industry Context
This recall is not presented as part of a broader industry pattern.
Real-World Impact
142 units across CA, IL, NJ are affected. Facilities should halt use and follow manufacturer instructions to limit disruption and safety risk.
Practical Guidance
How to identify if yours is affected
- Check model number SM-40HF-B-D-C
- Review UDI/DI 08436046001510 and serial numbers (e.g., G65281 and others)
- Confirm the unit was distributed to CA, IL, or NJ facilities
Where to find product info
Recall notices and updates are posted on the FDA enforcement page and through Sedecal communications.
What timeline to expect
Recall resolution timelines vary; typical processing can take 4-8 weeks for instructions and disposition.
If the manufacturer is unresponsive
- Document all contact attempts with Sedecal SA
- Escalate to your hospital's risk management and, if needed, contact FDA recall toll-free number for guidance
- Consider legal counsel if a provider experiences undue delays
How to prevent similar issues
- Ensure cleaning procedures strictly follow the manual for any imaging equipment
- Verify equipment is water-resistant or properly safeguarded against water exposure before use
- Establish a formal cleaning protocol and training for biomedical staff
- Audit inventory to identify any units that may require recall actions
Documentation advice
Keep the recall notice, email communications, serial numbers, UDI/DI details, and any correspondence with Sedecal SA for records
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Product Details
Model numbers: SM-40HF-B-D-C; 40KW, Mobile X-ray system. Sold to consignees in the United States (California, Illinois, New Jersey). When sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US distribution: CA, IL, NJ
- Model number: SM-40HF-B-D-C
- Not water-resistant; cleaning per manual required
- Hazard level: HIGH
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Safety Guide
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