Quick Facts at a Glance
- Recall Date
- June 10, 2025
- Hazard Level
- HIGH
- Brand
- SEDECAL SA
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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-20HF-Batt, UDI/DI 08436046001091, G23218
- Sold at
- Unknown
- 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-20HF-Batt is a portable, 20KW analog mobile X-ray system used in clinical settings for radiography. Hospitals and clinics rely on such systems for bedside imaging.
Why This Is Dangerous
The recall centers on the device not being water-resistant and the need to clean it exactly as described in the manual. Improper cleaning could compromise safety or equipment integrity.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Facilities with the device should halt use and review cleaning procedures to avoid potential damage or injury. The action is primarily operational and safety-focused rather than indicating current patient harm.
Practical Guidance
How to identify if yours is affected
- Check device label for model SM-20HF-Batt
- Verify UDI/DI 08436046001091 and Serial Number G23218
- Confirm the unit is within the distribution states (US: CA, IL, NJ; Canada)
- Review the manufacturer’s recall notice and FDA enforcement page
Where to find product info
Identifiers are on the device label and in the recall notice. UDI/DI is 08436046001091; Serial Number is G23218.
What timeline to expect
Remediation processing may take 4-8 weeks for refunds or replacements.
If the manufacturer is unresponsive
- Escalate to hospital risk management or the health authority
- File a complaint with the FDA if warranted
- Keep records of all correspondence
How to prevent similar issues
- Verify water resistance and cleaning requirements before purchase
- Follow the manual strictly for cleaning of any radiology equipment
- Use approved cleaning agents and procedures
- Verify device certification and service support contracts before deployment
Documentation advice
Save recall notices, document serial/UDI numbers, take photos of labels, keep all email communications and hospital risk management notes.
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Product Details
Model numbers: SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system. Sold in the United States (CA, IL, NJ) and Canada. Recall date: 2025-06-10. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model SM-20HF-Batt
- Serial Number G23218
- Distribution: US (CA, IL, NJ) and Canada
- Recall date: 2025-06-10; Status: ACTIVE
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Safety Guide
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