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-32HF-B-D-C
- 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-32HF-B-D-C is a 32KW 50G mobile X-ray system used in clinical settings for point-of-care radiography.
Why This Is Dangerous
The recall notes the equipment is not water-resistant and must be cleaned per the manual. Improper cleaning could have consequences described by the manufacturer.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals and clinics in the US and Canada may need to halt use of affected devices until proper cleaning and recall procedures are followed.
Practical Guidance
How to identify if yours is affected
- Look for model SM-32HF-B-D-C on the device label.
- Review the cleaning instructions in the manual.
- Review recall notice emailed to consignees.
Where to find product info
Serial numbers and model information are typically on the device data plate or user manual.
What timeline to expect
Timelines for refunds or replacements are not specified in the provided recall notice.
If the manufacturer is unresponsive
- File a complaint with the FDA recall portal if there are delays.
- Escalate within your healthcare facility safety program.
- Document all communications with the manufacturer.
How to prevent similar issues
- Verify cleaning procedures align with the manual before operation.
- Maintain separation of cleaning activities from electrical components.
- Train staff on recall requirements and cleaning protocols.
Documentation advice
Keep the recall notice, device serial numbers, model numbers, and all correspondence as records.
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Product Details
Model numbers: SM-32HF-B-D-C Distribution: US (CA, IL, NJ) and Canada Recall date: 2025-06-10 Quantity: 8 units Status: Active Brand: SEDECAL SA Note: Not water-resistant warning is in recall material.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US distribution: CA, IL, NJ; Canada
- Hazard: not water-resistant and cleaning must follow manual
- No injuries or incidents reported
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