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_VIR3.004, 08436046002166, G73023, G87352, G80066
- 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_VIR3.004 is a mobile X-ray system used in clinical settings to perform radiographs at the point of care.
Why This Is Dangerous
The unit is not water-resistant and requires cleaning per the manual. Improper cleaning could compromise device integrity or patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Three units are affected. Hospitals should stop use and follow recall instructions to prevent potential device damage or patient safety issues.
Practical Guidance
How to identify if yours is affected
- Locate the model SM_40HF_B_D_VIR3.004 on the device tag
- Check the UDI/DI: 08436046002166
- Verify serial numbers: G73023, G87352, G80066
Where to find product info
UDI/DI and serial numbers are on the device label and in the user manual PDF.
What timeline to expect
Not specified in the recall notice.
If the manufacturer is unresponsive
- Document all attempts to contact Sedecal SA
- Escalate to the facility's risk management or biomedical engineering team
- Consider filing a complaint with the FDA if the vendor is unresponsive
How to prevent similar issues
- Follow the manual for cleaning to prevent damage
- Verify device status before use in clinical settings
- Maintain documentation for all recall communications
Documentation advice
Keep the recall notice, emails, and any responses from Sedecal SA; photograph serial/UDI labels for records
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Product Details
Product: SM_40HF_B_D_VIR3.004 Mobile X-ray system Model/UDI: UDI/DI 08436046002166 Serial numbers: G73023, G87352, G80066 Sold in US states: CA, IL, NJ Quantity: 3 units Distribution: US Recall date: 2025-06-10 Manufacturer: Sedecal SA Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Serials: G73023, G87352, G80066
- Distributed to CA, IL, NJ
- Not water-resistant; cleaning per manual
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Safety Guide
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