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 Digital X-Ray System
- Model numbers
- SM-40HF-B-D-KM (AeroDR X30), UDI/DI 08436046002593
- 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
Sedecal mobile digital X-ray systems are used by healthcare facilities to perform portable radiographic imaging at the point of care. These units support diagnostics in wards, emergency rooms, and clinics.
Why This Is Dangerous
The devices are not water-resistant and require strict cleaning per the manual. Inadequate cleaning or exposure to moisture could compromise device function or safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Facilities may need to halt use of affected units and implement interim imaging options. The recall involves 56 units and service coordination with Sedecal SA.
Practical Guidance
How to identify if yours is affected
- 1) Locate the model number on the device label: SM-40HF-B-D-KM (AeroDR X30).
- 2) Confirm the UDI 08436046002593.
Where to find product info
Check the device label for model, UDI, and serial number plates. Manufacturer communications and the FDA recall page provide guidance.
What timeline to expect
Manufacturers typically offer a resolution within weeks to months, depending on stock and logistics.
If the manufacturer is unresponsive
- Document all contact attempts with Sedecal SA.
- Escalate to the FDA recall process if applicable.
- Consider consulting a healthcare compliance attorney if the company is unresponsive.
How to prevent similar issues
- Ask for water-resistance ratings and cleaning protocols before purchasing any new imaging device.
- Verify that service providers are trained on the specific model.
Documentation advice
Keep the recall notice, serial numbers list, purchase records, correspondence with Sedecal SA, and any replacement or refund documentation.
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Product Details
Model: SM-40HF-B-D-KM (AeroDR X30)\nUDI/DI: 08436046002593\nSerial Numbers: G-81478, G81924, G84618, G87981, G88006, G88007, G87866, G84607, G86618, G88041, G87427, G80991, G81936, G86688, G82904, G86360, G84340, G86372, G81471\nDistribution: United States (CA, IL, NJ)\nQuantity recalled: 56 units\nManufacturer: Sedecal SA\nRecall date: 2025-06-10
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 56 total units recalled
- Linked to AeroDR X30 platform
- Not water-resistant warning emphasized
- Serial numbers include G-81478, G81924, G84618, etc.
- Distribution to CA, IL, NJ
- Recall announcement date 2025-06-10
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Safety Guide
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