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, PREGNANT, ELDERLY
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, G25456, G25508, G25681, G25698, G25930, G27630 +13 more
- 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 Sedecal SM-40HF-B-D-C is a 40KW, 50G portable X-ray system used in medical imaging to perform radiographs at patient bedsides or in clinics.
Why This Is Dangerous
The device is not water-resistant. The manual requires strict cleaning procedures. Improper cleaning could affect device performance or safety.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Facilities must halt use and follow recall guidance. The action could disrupt imaging workflows and require device replacement or service coordination.
Practical Guidance
How to identify if yours is affected
- Identify model SM-40HF-B-D-C on the device label
- Confirm distribution region includes US CA IL NJ
Where to find product info
The FDA enforcement page for recall Z-0258-2026 and Sedecal communications
What timeline to expect
Refunds or replacements timelines are determined by Sedecal; monitor official updates
If the manufacturer is unresponsive
- Document all communications with Sedecal
- Contact the healthcare facility administrator for escalation
- File a complaint with the FDA if needed
How to prevent similar issues
- Verify cleaning guidelines before operating any non-water-resistant medical device
- Maintain updated device manuals and recall notices
- Establish a clear chain of communication with manufacturers
Documentation advice
Keep emails, recall notices, serial numbers, and service records as part of the recall file
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Product Details
Model Number SM-40HF-B-D-C; 40KW 50G mobile X-ray system. Quantity: 39 units. Distribution: United States and Canada (CA, IL, NJ). Recall date: 2025-06-10. Status: Active.
Reported Incidents
No formal incident counts of injuries or damages are provided in the recall notice. The hazard is described in terms of potential consequences of improper cleaning rather than documented injuries.
Key Facts
- Distribution includes US states CA, IL, NJ
- Model SM-40HF-B-D-C, 40KW 50G
- Hazard linked to improper cleaning of non-water-resistant device
- Recall status ACTIVE as of 2025-10-29
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Safety Guide
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