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
- 08436046001510, G41213
- 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_40HF_BDC3 is a mobile X-ray system used in medical facilities for diagnostic imaging in patient rooms and emergency settings.
Why This Is Dangerous
The device is not water-resistant and must be cleaned strictly according to the manual. Improper cleaning could create unsafe conditions or device malfunction.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Facilities should halt use to prevent potential safety concerns. The recall could affect operational workflows and replacement timelines.
Practical Guidance
How to identify if yours is affected
- Check UDI/DI 08436046001510 on the device label
- Check Serial Number G41213
- Confirm distribution region includes CA, IL, NJ
Where to find product info
Recall notice and manufacturer instructions via FDA enforcement page and SEDECAL SA communications.
What timeline to expect
No timeline for remedy is stated.
If the manufacturer is unresponsive
- Document communications with SEDECAL SA
- Escalate to hospital risk management
- Contact FDA if manufacturer is unresponsive
How to prevent similar issues
- Follow cleaning protocols exactly as described in the manual
- Do not expose non-waterproof devices to cleaning processes not approved by the manual
- Regularly audit cleaning procedures in clinical settings
Documentation advice
Keep the recall notice, identifiers, provider communications, and any replacement agreements for records
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model numbers: UDI/DI 08436046001510; Serial numbers: G41213. Where sold: United States (California, Illinois, New Jersey). When sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distributed in CA, IL, NJ in the US.
- Not water-resistant; cleaning per manual required.
- Immediate action: stop using the device and follow recall instructions.
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.